Product Code: LLZ FDA class 2 21 CFR 892.2050

System, Image Processing, Radiological

Radiology

System, Image Processing, Radiological is a software and hardware system used to process, enhance, manipulate, and analyze radiological images obtained from imaging modalities such as X-ray, CT, MRI, or nuclear medicine, facilitating interpretation and clinical decision-making. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLZ, regulated under 21 CFR 892.2050, within the Radiology medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

2222

FEI Numbers

609

Registration Numbers

609

Unique Applicants

1179

Years Active

Basic Information

Product Code: LLZ
Device Class: FDA class 2
Regulation Number: 892.2050
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 2222 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251863	CustomSurg OrthoPlanner	Jul 07, 2025	Substantially Equivalent	CustomSurg AG
K243666	uOmniscan	Jun 17, 2025	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K244012	Mosaic (V1.0.1)	Jun 16, 2025	Substantially Equivalent	Navier Medical
K250800	UroNav 4	Jun 05, 2025	Substantially Equivalent	Philips DS North America LLC
K243703	TechLive	Jun 05, 2025	Substantially Equivalent	DeepHealth, Inc.
K251109	SMARTDent	May 21, 2025	Substantially Equivalent	RAY Co., Ltd.
K243632	uWS-Angio Basic	May 12, 2025	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K243069	LUMYS (V1)	May 02, 2025	Substantially Equivalent	INTRADYS
K243697	MySpine WebPlanner	Apr 23, 2025	Substantially Equivalent	Medacta International S.A.
K243651	VersaViewer	Apr 21, 2025	Substantially Equivalent	GE Medical Systems SCS
K242647	MySegmenter (v2.0.0)	Apr 16, 2025	Substantially Equivalent	MySegmenter Technologies Inc.
K250301	Merge Universal Viewer (MUV)	Apr 14, 2025	Substantially Equivalent	Merge Healthcare Incorporated
K242552	Horos Mobile	Apr 08, 2025	Substantially Equivalent	iCat Solutions Ltd
K243292	brAIn Shoulder Positioning	Mar 20, 2025	Substantially Equivalent	Avatar Medical
K242161	Radlink GPS Pro Imaging	Mar 18, 2025	Substantially Equivalent	Radlink, Inc.
K241975	SERV MEDICAL CDSS	Mar 17, 2025	Substantially Equivalent	Serv Medical Pte. Ltd
K241765	PLANET Onco Dose (3.2)	Mar 14, 2025	Substantially Equivalent	DOSIsoft SA
K241546	aiCockpit AI Viewer	Feb 26, 2025	Substantially Equivalent	Fovia, Inc.
K250348	JLK-AILink	Feb 25, 2025	Substantially Equivalent	JLK, Inc.
K242838	QuickRad	Feb 21, 2025	Substantially Equivalent	Aikenist Technologies Pvt Ltd
K242240	CaRi-Plaque	Feb 20, 2025	Substantially Equivalent	Caristo Diagnostics Ltd.
K241425	AspenView	Feb 12, 2025	Substantially Equivalent	Aspen Imaging Healthcare Inc
K243333	rTOP	Feb 04, 2025	Substantially Equivalent	roclub GmbH
K241694	ZeTTA PACS	Jan 31, 2025	Substantially Equivalent	Tae Young Soft Co., Ltd.
K241819	CephNinja	Jan 23, 2025	Substantially Equivalent	Cyncronus LLC
K242205	SpectoMed (v1.0)	Jan 14, 2025	Substantially Equivalent	Specto Medical
K241808	ApolloHipX (THR.SS.0001)	Jan 07, 2025	Substantially Equivalent	Corin USA Limited
K242123	Brainomix 360 e-CTA	Jan 06, 2025	Substantially Equivalent	Brainomix Limited
K241350	Clarify DL	Jan 03, 2025	Substantially Equivalent	GE Medical Systems Israel, Functional Imaging
K242599	aprevo® Digital Planning	Dec 20, 2024	Substantially Equivalent	Carlsmed, Inc.
K242362	Lightning Viewer	Dec 20, 2024	Substantially Equivalent	Nexsys Electronics Inc. dba Medweb
K241989	Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert	Dec 06, 2024	Substantially Equivalent	Cercare Medical A/S
K240926	PeekMed web	Dec 06, 2024	Substantially Equivalent	Peek Health, S.A.
K243447	Rapid Surgical Plan (RSP-SW-001)	Dec 05, 2024	Substantially Equivalent	Navbit Pty Ltd
K242810	RadUnity (Version 1.0.0)	Nov 26, 2024	Substantially Equivalent	RadUnity Corp.
K241495	Jazz Classic	Nov 21, 2024	Substantially Equivalent	Jazz Imaging
K242329	CT Collaboration Live	Nov 18, 2024	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd
K242062	1CMR Pro	Nov 15, 2024	Substantially Equivalent	Mycardium AI Limited
K241981	Change Healthcare Stratus Imaging PACS	Nov 12, 2024	Substantially Equivalent	Change Healthcare Canada Company
K242709	JLK-PWI	Nov 04, 2024	Substantially Equivalent	JLK, Inc.
K241223	eRAD PACS	Oct 31, 2024	Substantially Equivalent	eRAD, Inc.
K242512	ROCC Console	Oct 24, 2024	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K243012	MIM Symphony HDR Fusion	Oct 23, 2024	Substantially Equivalent	MIM Software Inc.
K243209	nordicMEDiVA	Oct 22, 2024	Substantially Equivalent	NordicNeurolab AS
K242556	JLK-CTP	Oct 16, 2024	Substantially Equivalent	JLK, Inc.
K240385	VINT	Oct 15, 2024	Substantially Equivalent	Mediimg Corporation
K241569	syngo Application Software	Oct 11, 2024	Substantially Equivalent	Siemens Medical Solutions USA, Inc
K240243	EConsole2	Sep 23, 2024	Substantially Equivalent	DRTECH Corporation
K241524	Elucid PlaqueIQ	Sep 12, 2024	Substantially Equivalent	Elucid Bioimaging, Inc.
K233998	TRAQinform IQ	Sep 05, 2024	Substantially Equivalent	AIQ Global, Inc.
K241302	SonoSync	Aug 23, 2024	Substantially Equivalent	Samsung Medison Co., Ltd.
K240290	AiMIFY (1.x)	Aug 21, 2024	Substantially Equivalent	Subtle Medical, Inc.
K241094	Bullsai	Aug 13, 2024	Substantially Equivalent	Turing Medical Technologies, Inc.
K240724	SynthVISION 1.0.0	Aug 08, 2024	Substantially Equivalent	Synthesis Health Intelligence Inc
K233761	Orthopaedic Surgery Planning Software (AIJOINT)	Aug 05, 2024	Substantially Equivalent	Longwood Valley Medical Ltd
K241114	EzDent-i / E2 / Prora View / Smart M Viewer (v3.5)	Jul 23, 2024	Substantially Equivalent	EwooSoft Co., Ltd.
K241879	vRad Viewer	Jul 18, 2024	Substantially Equivalent	Virtual Radiologic Corporation
K241121	MICSI-RMT	Jul 17, 2024	Substantially Equivalent	Microstructure Imaging, Inc.
K240705	Vitrea Software Package, VSTP-002A V2.0	Jul 17, 2024	Substantially Equivalent	Canon Medical Systems Corporation
K241300	ViewPoint 6	Jul 02, 2024	Substantially Equivalent	GE Healthcare GmbH
K233908	cNeuro cDAT	Jul 01, 2024	Substantially Equivalent	Combinostics Oy
K241608	nordicMEDiVA	Jun 28, 2024	Substantially Equivalent	NordicNeuroLab AS
K233331	MediOMx	Jun 17, 2024	Substantially Equivalent	PMX Inc.
K240281	Bone Suppression Software	May 31, 2024	Substantially Equivalent	Konica Minolta, Inc.
K223427	Mimics Enlight CMF	May 31, 2024	Substantially Equivalent	Materialise NV
K240294	Syngo Carbon Enterprise Access (VA40A)	May 23, 2024	Substantially Equivalent	Siemens Healthcare GmbH
K232759	Viewer (5.4); Elements Viewer; Mixed Reality Viewer; Smart Layout; Elements Viewer Smart Layout	May 21, 2024	Substantially Equivalent	Brainlab AG
K233620	MIM - Centiloid Scaling	May 20, 2024	Substantially Equivalent	MIM Software Inc.
K232862	MIM Monte Carlo Dosimetry	May 13, 2024	Substantially Equivalent	MIM Software Inc.
K232976	VUZE System	May 09, 2024	Substantially Equivalent	VUZE Medical Ltd.
K232514	MIM Dose Analysis	May 06, 2024	Substantially Equivalent	MIM Software Inc.
K233699	SubtleREFORMAT (1.x)	Apr 29, 2024	Substantially Equivalent	Subtle Medical, Inc.
K240839	OpenRad Cloud	Apr 24, 2024	Substantially Equivalent	OpenRad Services UK Ltd
K240822	Image Management V15	Apr 24, 2024	Substantially Equivalent	Philips Medical Systems Technologies
K233582	Rapid	Apr 22, 2024	Substantially Equivalent	iSchema View Inc.
K232641	Neorad Pacs (Neorad Pacs)	Apr 10, 2024	Substantially Equivalent	Everrtech Software PVT LTD
K232891	CARPL (CARPL)	Mar 27, 2024	Substantially Equivalent	Carpl AI Inc.
K240620	Cube Navigator	Mar 25, 2024	Substantially Equivalent	Medical Templates AG
K233660	nCommand Lite System	Mar 18, 2024	Substantially Equivalent	Ionic Health
K233599	X-Clever (ASHK100G)	Mar 18, 2024	Substantially Equivalent	LG Electronics Inc.
K233930	MRCP+ version 2 (MRCP+ v2)	Mar 13, 2024	Substantially Equivalent	Perspectum
K233572	Autofuse	Mar 06, 2024	Substantially Equivalent	Pymedix
K233217	Mimics Cardiac Planner	Feb 12, 2024	Substantially Equivalent	Materialise N.V.
K231662	Aid-U	Feb 08, 2024	Substantially Equivalent	iAID
K232339	Augmented Reality Application	Feb 01, 2024	Substantially Equivalent	Sira Medical, Inc.
K232007	CAAS MR Solutions	Feb 01, 2024	Substantially Equivalent	Pie Medical Imaging B.V.
K231396	CEPHX- Cephalometric Analysis Software	Jan 31, 2024	Substantially Equivalent	Orca Dental AI LTD
K233714	BreView	Jan 25, 2024	Substantially Equivalent	GE Medical Systems SCS
K231607	Axial3D Cloud Segmentation Service	Jan 24, 2024	Substantially Equivalent	Axial Medical Printing Limited
K233226	FlexView Diagnostic (v1.1.20)	Jan 17, 2024	Substantially Equivalent	Radical Imaging, LLC
K232589	Horos MD	Jan 03, 2024	Substantially Equivalent	iCat Solutions Ltd
K232744	syngo Virtual Cockpit (VB10A)	Dec 21, 2023	Substantially Equivalent	Siemens Healthcare GmbH
K233176	uOmnispace.MI	Dec 20, 2023	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K230955	syngo Application Software	Dec 20, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K231570	StrokeViewer Perfusion	Dec 14, 2023	Substantially Equivalent	NICo-Lab B.V.
K233634	TeleScan	Dec 12, 2023	Substantially Equivalent	BB Imaging
K231898	DTX Studio Clinic (4.0)	Dec 08, 2023	Substantially Equivalent	Nobel Biocare AB
K232661	Myocardial Strain Software Application	Dec 07, 2023	Substantially Equivalent	Circle Cardiovascular Imaging
K231498	TraumaCad Neo	Nov 20, 2023	Substantially Equivalent	Brainlab Ltd.
K230856	BrainSpec Core Software	Nov 14, 2023	Substantially Equivalent	BrainSpec, Inc
K230854	SwiftMR	Oct 27, 2023	Substantially Equivalent	AIRS Medical Inc.
K232086	spineEOS	Oct 24, 2023	Substantially Equivalent	EOS imaging
K223909	R2GATE Lite TM	Oct 20, 2023	Substantially Equivalent	MegaGen Implant Co. Ltd
K231225	EConsole1	Oct 18, 2023	Substantially Equivalent	DRTECH Corporation
K230249	Ikshana	Oct 16, 2023	Substantially Equivalent	ImmersiveTouch
K231642	Veuron-Brain-pAb3	Oct 13, 2023	Substantially Equivalent	Heuron Co., Ltd.
K230252	OFIX MIS App	Sep 26, 2023	Substantially Equivalent	Orthofix US LLC
K223659	Jazz	Sep 22, 2023	Substantially Equivalent	AI Medical AG
K231385	Rology Teleradiology Platform (v.1.22.1103)	Sep 20, 2023	Substantially Equivalent	Rology Inc.
K232189	OrionXR	Sep 14, 2023	Substantially Equivalent	Hoth Intelligence Inc.
K231353	AccuCTP Pro	Sep 14, 2023	Substantially Equivalent	ArteryFlow Technology Co., Ltd.
K220034	NEUROShield	Sep 14, 2023	Substantially Equivalent	In-Med Prognostics L3C
K231047	UniSyn Molecular Imaging (6-3-1)	Sep 01, 2023	Substantially Equivalent	Convergent Imaging Solutions
K231656	Brainomix 360 e-MRI	Aug 30, 2023	Substantially Equivalent	Brainomix Limited
K223180	AIRAscore	Aug 25, 2023	Substantially Equivalent	AIRAmed GmbH
K231503	CUPTIMIZE Advanced	Aug 22, 2023	Substantially Equivalent	DePuy Orthopaedics, Inc
K223660	SaintView	Aug 14, 2023	Substantially Equivalent	Inviz Corporation
K232100	Efai Pacs Picture Archiving and Communication System Pro	Aug 08, 2023	Substantially Equivalent	Ever Fortune.AI Co., Ltd.
K230540	Patient Specific Planning Solution 3D Bone Models	Jul 25, 2023	Substantially Equivalent	Biomet Manufacturing Corp.
K223322	Argus Cognitive ReVISION Software	Jul 24, 2023	Substantially Equivalent	Argus Cognitive, Inc.
K222683	Fibroid Mapping Reviewer Application (FMRA)	Jul 17, 2023	Substantially Equivalent	Nesa Medtech Private Limited
K231041	JiveX (Model Number / Release: 5.4)	Jul 14, 2023	Substantially Equivalent	VISUS Health IT GmbH
K230016	Cercare Medical Neurosuite	Jul 14, 2023	Substantially Equivalent	Cercare Medical A/S
K223290	CommandEP Data Manager PC (DPC02), CommandEP HMD (HMD02)	Jul 14, 2023	Substantially Equivalent	SentiAR, Inc.
K231351	Chondral Quant	Jul 13, 2023	Substantially Equivalent	Siemens Medical Soultions USA, Inc.
K223125	XR90 (XR90-SYS)	Jul 13, 2023	Substantially Equivalent	MediView XR, Inc.
K213253	Pixyl.Neuro	Jun 30, 2023	Substantially Equivalent	Pixyl SA
K223048	Medisystem Pacs	Jun 23, 2023	Substantially Equivalent	Medilab Manutencao E Sitemas Ltda
K223091	CT Perfusion V1.0	Jun 09, 2023	Substantially Equivalent	Olea Medical
K231360	Ambra PACS	Jun 07, 2023	Substantially Equivalent	DICOM Grid dba Ambra Health
K223532	Olea S.I.A. Neurovascular V1.0	Jun 06, 2023	Substantially Equivalent	Olea Medical
K223555	Brainomix 360 e-CTP	Jun 01, 2023	Substantially Equivalent	Brainomix Limited
K223841	KBA3D	May 30, 2023	Substantially Equivalent	S.M.A.I.O.
K222359	Quicktome Software Suite	May 30, 2023	Substantially Equivalent	Omniscient Neurotechnology Pty Ltd (O8t)
K230044	Pre-Sure	May 26, 2023	Substantially Equivalent	Lazarus 3D
K222035	Avatar Medical Software V1	May 24, 2023	Substantially Equivalent	Avatar Medical
K231162	ROSA Hip System	May 23, 2023	Substantially Equivalent	Orthosoft, Inc (d/b/a Zimmer CAS)
K230803	ADAS 3D	May 23, 2023	Substantially Equivalent	Adas3D Medical S.L
K212758	Autoplaque	May 19, 2023	Substantially Equivalent	Cedars-Sinai Medical Center: AIM
K222854	iTFlow	May 12, 2023	Substantially Equivalent	Cardio Flow Design Inc.
K223623	SubtleMR (2.3.x)	May 11, 2023	Substantially Equivalent	Subtle Medical Inc.
K222987	Akunah REFLECT	May 10, 2023	Substantially Equivalent	Akunah PTY LTD
K220437	Neurophet AQUA	May 10, 2023	Substantially Equivalent	NEUROPHET, Inc.
K230119	3D Anatomic Model	May 02, 2023	Substantially Equivalent	Ricoh USA, Inc.
K221870	CarnaLife Holo	May 01, 2023	Substantially Equivalent	MedApp S.A.
K230552	MR DWI/FLAIR Measurement V1.0	Apr 26, 2023	Substantially Equivalent	Olea Medical
K230906	Konicaminolta DI-X1	Apr 25, 2023	Substantially Equivalent	Konica Minolta, Inc.
K230468	EzDent Web	Apr 21, 2023	Substantially Equivalent	Ewoosoft Co., Ltd
K230772	Quantib Prostate	Apr 17, 2023	Substantially Equivalent	Quantib BV
K230393	UniCam Evo Software	Apr 13, 2023	Substantially Equivalent	Inter Medical Medizintechnik GmbH
K230264	Ezra Flash	Apr 13, 2023	Substantially Equivalent	Ezra AI, Inc.
K222781	Augmento	Apr 11, 2023	Substantially Equivalent	Deeptek Medical Imaging Private Limited
K230575	Limbus Contour	Apr 07, 2023	Substantially Equivalent	Limbus AI Inc.
K213660	RadAlly	Mar 31, 2023	Substantially Equivalent	Imaging Wave, LLC
K211059	CereFlow V1.2	Mar 31, 2023	Substantially Equivalent	Translational MRI, LLC
K221984	InterView XP; InterView FUSION	Mar 29, 2023	Substantially Equivalent	Mediso Medical Imaging Systems, LTtd.
K230561	Syngo Carbon Space VA30A	Mar 21, 2023	Substantially Equivalent	Siemens Healthcare GmBH
K223490	FlightPlan for Embolization	Mar 21, 2023	Substantially Equivalent	GE Medical Systems SCS
K230294	CoverScan (CoverScan v1.1)	Mar 03, 2023	Substantially Equivalent	Perspectum
K222975	Advantis Platform	Mar 01, 2023	Substantially Equivalent	Advantis Medical Imaging Single Member P.C.
K221680	Xeleris V Processing and Review System	Mar 01, 2023	Substantially Equivalent	GE Healthcare
K222757	Clarus Viewer	Feb 24, 2023	Substantially Equivalent	Clarus Viewer Corporation
K213891	RealNow	Feb 24, 2023	Substantially Equivalent	YIWEI Medical Technology Co., Ltd
K223820	EzDent-i / E2 / Prora View/ Smart M Viewer	Feb 17, 2023	Substantially Equivalent	Ewoosoft Co., Ltd
K230196	syngo.via View&GO VA40A	Feb 13, 2023	Substantially Equivalent	Siemens Healthcare GmBH
K223425	MD.ai Viewer	Feb 10, 2023	Substantially Equivalent	MDAI Inc
K230012	Atomica Planner	Feb 02, 2023	Substantially Equivalent	Atomica Technology, Inc.
K221725	Advanced MyHip Planner	Jan 20, 2023	Substantially Equivalent	Medacta International S.A.
K221627	PerfusionGo Plus	Jan 19, 2023	Substantially Equivalent	Yukun (Beijing) Technology Co., Ltd.
K222593	TruPlan Computed Tomography (CT) Imaging Software	Jan 18, 2023	Substantially Equivalent	Circle Cardiovascular Imaging, Inc.
K223800	MIM Additional Tracers	Jan 17, 2023	Substantially Equivalent	MIM Software Inc.
K220649	Elucis	Jan 17, 2023	Substantially Equivalent	Realize Medical Inc.
K223502	MR Diffusion Perfusion Mismatch V1.0	Jan 13, 2023	Substantially Equivalent	Olea Medical
K223363	MAMMOVISTA B.smart (VB70)	Jan 12, 2023	Substantially Equivalent	Siemens Medical Solutions USA Inc.
K222458	AIBOLIT 3D+	Jan 12, 2023	Substantially Equivalent	Aibolit Technologies, LLC
K223336	Vitrea Software Package, VSTP-002A	Jan 09, 2023	Substantially Equivalent	Canon Medical Systems Corporation
K222577	TECHFIT Diagnostic Models	Jan 06, 2023	Substantially Equivalent	TECHFIT Digital Surgery Inc.
K213263	OnyxCeph	Jan 04, 2023	Substantially Equivalent	Image Instruments GmbH
K222767	PeekMed web (v1)	Dec 30, 2022	Substantially Equivalent	Peek Health, S.A.
K222195	aprevo® Digital Workflow	Dec 30, 2022	Substantially Equivalent	Carlsmed, Inc.
K221796	Cyware 4H and Cysart 4H	Dec 30, 2022	Substantially Equivalent	Abys Medical
K223071	Xenoview VDP	Dec 23, 2022	Substantially Equivalent	Polarean, Inc.
K222320	MedDream	Dec 06, 2022	Substantially Equivalent	Softneta UAB
K220630	TorchTM Software	Nov 28, 2022	Substantially Equivalent	Voximetry, Incorporated
K213215	VSI HoloMedicine	Nov 25, 2022	Substantially Equivalent	ApoQlar GmbH
K223152	Vision 2, EVARVision, TrackVision 2, HeartVision 2	Nov 22, 2022	Substantially Equivalent	GE Medical Systems SCS
K222054	Denti.AI Auto-Chart	Nov 22, 2022	Substantially Equivalent	Denti.AI Technology Inc.
K221499	Minimally Invasive Prostate Surgery Navigation System	Nov 22, 2022	Substantially Equivalent	Augment Intelligent Medical System (China) Co., Ltd.
K220663	AccuCTP	Nov 22, 2022	Substantially Equivalent	ArteryFlow Technology Co., Ltd.
K222476	OmegaAI Image Viewer	Nov 17, 2022	Substantially Equivalent	RamSoft Inc.
K221677	Synapse 3D Base Tools v6.6	Nov 10, 2022	Substantially Equivalent	FUJIFILM Corporation
K221478	Dolphin Blue Imaging	Nov 01, 2022	Substantially Equivalent	Patterson Dental Supply, Inc.
K222470	3Dicom MD	Oct 25, 2022	Substantially Equivalent	Singular Health Pty Ltd
K213128	IntraOp VSP Software Device	Oct 21, 2022	Substantially Equivalent	Xironetic, LLC
K222662	Vitrea CT Cardiac Analysis	Oct 14, 2022	Substantially Equivalent	Canon Medical Informatics, Inc.
K221501	syngo.via View&GO	Oct 14, 2022	Substantially Equivalent	Siemens Healthcare GmBH
K220758	e-Ortho Shoulder Software v1.1	Sep 30, 2022	Substantially Equivalent	FH Industrie
K222069	Ez3D-i/E3	Sep 06, 2022	Substantially Equivalent	Ewoosoft Co., Ltd
K213520	AXIR-CX	Aug 19, 2022	Substantially Equivalent	Radisen Co., Ltd
K220903	WebCeph	Aug 17, 2022	Substantially Equivalent	AssembleCircle Corp.
K220433	syngo Application Software (VE21)	Aug 16, 2022	Substantially Equivalent	Siemens Medical Solution USA, Inc.
K222145	EzDent-i / E2 / Prora View/ Smart M Viewer	Aug 12, 2022	Substantially Equivalent	Ewoosoft Co., Ltd
K220349	TeraRecon Neuro	Aug 12, 2022	Substantially Equivalent	TeraRecon, Inc
K222072	Dolphin Imaging 12.0	Aug 08, 2022	Substantially Equivalent	Patterson Dental Supply, Inc
K221405	Neurophet SCALE PET	Aug 05, 2022	Substantially Equivalent	NEUROPHET, Inc.
K220733	OptiVu ROSA MxR	Jul 29, 2022	Substantially Equivalent	Orthosoft, Inc. (d/b/a Zimmer CAS)
K220624	AI4CMR v1.0	Jul 22, 2022	Substantially Equivalent	AI4MedImaging Medical Solutions S.A.
K213922	FX SPS	Jul 22, 2022	Substantially Equivalent	Pixee Medical
K220039	AutoSeg	Jul 20, 2022	Substantially Equivalent	AI Medic Inc.
K221426	Functional MR V1.0	Jul 06, 2022	Substantially Equivalent	Olea Medical SAS
K221511	Axial3D Cloud Segmentation Service	Jun 23, 2022	Substantially Equivalent	Axial Medical Printing Limited
K213665	Syngo Carbon Space VA20A	Jun 21, 2022	Substantially Equivalent	Siemens Healthcare GmbH
K221463	ElucidVivo A.3	Jun 17, 2022	Substantially Equivalent	Elucid Bioimaging Inc.
K213684	SurgiCase Viewer	Jun 15, 2022	Substantially Equivalent	Materialise NV
K221065	MediLab	Jun 10, 2022	Substantially Equivalent	Sigma Scientific Services LLC
K220205	3D Anatomic Models	Jun 03, 2022	Substantially Equivalent	Ricoh USA, Inc.
K221270	EchoNavigator R4.0	May 31, 2022	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K220416	SwiftMR	May 25, 2022	Substantially Equivalent	AIRS Medical Inc.
K221000	ON3D	May 23, 2022	Substantially Equivalent	3D ONS, Inc.
K220832	syngo Dynamics (Version VA40E)	May 20, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K212565	CoverScan v1	May 19, 2022	Substantially Equivalent	Perspectum Ltd.
K212376	Caas Qardia	May 16, 2022	Substantially Equivalent	Pie Medical Imaging B.V.
K221106	Quantib Prostate	May 13, 2022	Substantially Equivalent	Quantib BV
K220727	inHEART MODELS	May 10, 2022	Substantially Equivalent	inHEART, SAS
K213975	KEOPS Balance Analyzer 3D	May 06, 2022	Substantially Equivalent	S.M.A.I.O
K211966	Segment 3DPrint	May 06, 2022	Substantially Equivalent	Medviso AB
K213302	exoplan	May 03, 2022	Substantially Equivalent	exocad GmbH
K220684	Oryx Cloud Imaging	Apr 29, 2022	Substantially Equivalent	Oryx Dental Software INC
K220590	aPROMISE X	Apr 29, 2022	Substantially Equivalent	EXINI Diagnostics AB
K211713	AngioCloud Service	Apr 28, 2022	Substantially Equivalent	AngioCloud, LLC
K212981	MirrorMe3D Modeling System	Apr 22, 2022	Substantially Equivalent	MirrorMe3D, LLC
K220779	XD	Apr 15, 2022	Substantially Equivalent	Mirada Medical Ltd
K220767	TeleScan	Apr 14, 2022	Substantially Equivalent	BB Imaging
K203783	ClariPulmo	Apr 06, 2022	Substantially Equivalent	ClariPi Inc.
K213562	DTX Studio Clinic 3.0	Mar 25, 2022	Substantially Equivalent	Nobel Biocare AB
K212040	RI.HIP MODELER	Mar 11, 2022	Substantially Equivalent	Blue Belt Technologies, Inc.
K212720	nordicDSC	Mar 03, 2022	Substantially Equivalent	NordicNeurolab AS
K220003	EzOrtho v1.3	Feb 23, 2022	Substantially Equivalent	Ewoosoft Co., Ltd
K213165	Rapid	Feb 08, 2022	Substantially Equivalent	iSchema View Inc.
K213801	Veuron-Brain-pAb2	Feb 04, 2022	Substantially Equivalent	Heuron Co., Ltd.
K213737	Quantib ND	Jan 14, 2022	Substantially Equivalent	Quantib B.V.
K212005	UNiD Spine Analyzer	Jan 12, 2022	Substantially Equivalent	MEDICREA International, Inc.
K211443	AIBOLIT 3D+	Jan 07, 2022	Substantially Equivalent	AIbolit Technologies, LLC
K210830	VUZE System	Jan 03, 2022	Substantially Equivalent	VUZE Medical Ltd.
K211156	CONVIVO In Vivo Pathology Suite	Dec 29, 2021	Substantially Equivalent	Carl Zeiss Meditec AG
K213140	Claritas iPET	Dec 22, 2021	Substantially Equivalent	Claritas HealthTech Pte Ltd
K210931	Libby IAAA v1.0	Dec 17, 2021	Substantially Equivalent	Dyad Medical, Inc.
K212420	Brainlab Elements, Brainlab Elements Contouring, Brainlab Elements Fibertracking, Brainlab Elements Image Fusion, Brainlab Elements Image Fusion Angio	Dec 16, 2021	Substantially Equivalent	Brainlab AG
K211114	Will3D	Dec 15, 2021	Substantially Equivalent	HDX WILL CORP.
K211039	BIT-Motion	Dec 15, 2021	Substantially Equivalent	DDE MRI Solutions LTD
K212137	X-Clever	Dec 10, 2021	Substantially Equivalent	LG Electronics.Inc
K203743	EXA	Dec 10, 2021	Substantially Equivalent	Konica Minolta Healthcare Americas, Inc.
K210916	PVmed Contouring Software	Dec 03, 2021	Substantially Equivalent	Perception Vision Medical Technologies LTD.CO.
K210241	ImplaStation	Dec 03, 2021	Substantially Equivalent	Prodigident, Inc.
K211432	Myomics Q	Nov 23, 2021	Substantially Equivalent	Phantomics Inc.
K212984	MiPACS HTML5 Web Viewer	Nov 12, 2021	Substantially Equivalent	LEAD Technologies Inc.
K212621	MAMMOVISTA B.smart	Nov 12, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K211876	Intellijoint VIEW	Nov 12, 2021	Substantially Equivalent	Intellijoint Surgical Inc.
K212887	RTapp	Nov 10, 2021	Substantially Equivalent	SegAna, Inc.
K210344	inVisionOS	Nov 10, 2021	Substantially Equivalent	PrecisionOS Technology Inc.
K212550	Hura CTP v1.0	Nov 08, 2021	Substantially Equivalent	Hura Imaging, Inc.
K211356	GIQuant	Nov 08, 2021	Substantially Equivalent	Motilent Ltd
K212896	Visible Patient Suite	Nov 05, 2021	Substantially Equivalent	Visible Patient, SAS
K213326	VisionX 3.0	Nov 02, 2021	Substantially Equivalent	Durr Dental SE
K211987	ATEC Alignment App	Oct 29, 2021	Substantially Equivalent	Alphatec Spine, Inc.
K210807	FlightPlan for Liver	Oct 22, 2021	Substantially Equivalent	GE Medical Systems SCS
K212470	iRAD	Oct 20, 2021	Substantially Equivalent	Claritas HealthTech Pte Ltd
K212528	Change Healthcare Cardiology	Oct 18, 2021	Substantially Equivalent	Change Healthcare Israel Ltd.
K210999	SwiftMR	Oct 14, 2021	Substantially Equivalent	AIRS Medical Inc.
K202808	Brainance MD	Oct 14, 2021	Substantially Equivalent	Advantis Medical Imaging Single Member P.C.
K211429	NAVIPLAN - CT Planning Software for Total Hip Replacement	Oct 05, 2021	Substantially Equivalent	Naviswiss AG
K211795	EzDent-i/ E2/ Prora View/ Smart M Viewer	Oct 04, 2021	Substantially Equivalent	Ewoosoft Co., Ltd.
K210726	ImmersiveTouch	Sep 29, 2021	Substantially Equivalent	ImmersiveTouch, Inc.
K211700	EzDent Web	Sep 28, 2021	Substantially Equivalent	Ewoosoft Co., Ltd
K212777	Collaboration Live	Sep 24, 2021	Substantially Equivalent	Philips Ultrasound, Inc.
K212321	JiveX (Model Number / Release: 5.3)	Sep 23, 2021	Substantially Equivalent	Visus Health IT GmbH
K212685	KONICAMINOLTA DI-X1	Sep 13, 2021	Substantially Equivalent	Konica Minolta, Inc.
K211257	EFAI PACS Picture Archiving and Communication System	Sep 10, 2021	Substantially Equivalent	Ever Fortune.AI Co., Ltd.
K202056	Kinepict Medical Imaging Tool 4.0	Sep 10, 2021	Substantially Equivalent	Kinepict Health Ltd
K212421	ADAS 3D	Sep 03, 2021	Substantially Equivalent	Adas3D Medical S.L
K203696	RBknee	Aug 27, 2021	Substantially Equivalent	Radiobotics ApS
K211793	EzOrtho	Aug 23, 2021	Substantially Equivalent	Ewoosoft Co., Ltd
K211791	Ez3D-i/E3	Aug 20, 2021	Substantially Equivalent	Ewoosoft Co., Ltd
K210998	ROSA Hip System	Aug 17, 2021	Substantially Equivalent	Orthosoft d/b/a Zimmer CAS
K201573	Brain Perfusion (BP) application	Aug 17, 2021	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K212230	TruSPECT Radiological Image Processing Station	Aug 16, 2021	Substantially Equivalent	Spectrum Dynamics Medical Ltd
K211863	eVolve PACS	Aug 12, 2021	Substantially Equivalent	eVolve PACS Inc.
K212175	DynaCAD	Aug 02, 2021	Substantially Equivalent	Invivo Corporation
K212074	ClariCT.AI	Jul 27, 2021	Substantially Equivalent	ClariPi Inc.
K211655	aPROMISE	Jul 27, 2021	Substantially Equivalent	EXINI Diagnostics AB
K211279	Volpara Imaging Software	Jul 27, 2021	Substantially Equivalent	Volpara Health Technologies Limited
K211386	MySpine WebPlanner & MyBalance	Jul 23, 2021	Substantially Equivalent	Medacta International SA
K203765	ZIRKONZAHN.Implant-Planner, ZIRKONZAHN.Implant-Planner Practice, CAD/CAM STL Converter, CAD/CAM Z-Tray	Jul 20, 2021	Substantially Equivalent	Zirkonzahn SRL
K211480	NubeX	Jul 08, 2021	Substantially Equivalent	TechHeim Co., Ltd
K201835	PRE-SURE	Jul 08, 2021	Substantially Equivalent	Lazarus, 3D, Inc
K210653	ONE Planner Hip	Jul 07, 2021	Substantially Equivalent	Orthosoft d/b/a Zimmer CAS
K211656	3D Echo v1.1	Jun 25, 2021	Substantially Equivalent	JointVue LLC
K202718	Qmenta Care Platform Family	Jun 16, 2021	Substantially Equivalent	Mint Labs, Inc., d/b/a. QMENTA
K200704	ZedView	May 27, 2021	Substantially Equivalent	Lexi Co., Ltd.
K211312	Universal Viewer	May 21, 2021	Substantially Equivalent	GE Healthcare
K210257	Xoran Workstation, Model 10050	May 20, 2021	Substantially Equivalent	Xoran Technologies LLC
K210187	Overjet Dental Assist	May 19, 2021	Substantially Equivalent	Overjet, Inc.
K202793	Cercare Medical Neurosuite	May 17, 2021	Substantially Equivalent	Cercare Medical ApS
K210072	HOLOSCOPE-i	May 14, 2021	Substantially Equivalent	Real View Imaging Ltd.
K210066	ImagePilot	May 06, 2021	Substantially Equivalent	Konica Minolta, Inc.
K210682	SOTA Cloud Imaging	May 04, 2021	Substantially Equivalent	Sota Precision Optics, Inc. dba SOTA Imaging
K202521	PtoleMedic System	May 04, 2021	Substantially Equivalent	Lento Medical Innovation, Inc.
K202084	DeepLook PRECISE	Apr 09, 2021	Substantially Equivalent	DeepLook Inc.
K210850	ADAS 3D	Apr 05, 2021	Substantially Equivalent	Adas3D Medical S.L
K203195	Simpleware ScanIP Medical	Apr 01, 2021	Substantially Equivalent	Synopsys (Northern Europe) Ltd.
K210071	SIS System (Version 5.1.0)	Mar 31, 2021	Substantially Equivalent	Surgical Information Sciences, Inc.
K203518	Quicktome	Mar 09, 2021	Substantially Equivalent	Omniscient Neurotechnology Pty Ltd (o8t)
K203651	Cuptimize	Feb 26, 2021	Substantially Equivalent	Cuptimize, Inc.
K203182	SubtleMR	Feb 26, 2021	Substantially Equivalent	Subtle Medical, Inc.
K202990	NinesMeasure	Feb 25, 2021	Substantially Equivalent	Nines, Inc.
K202212	TruPlan	Feb 19, 2021	Substantially Equivalent	Circle Cardiovascular Imaging Inc.
K200589	MyPAO Planning Report	Feb 19, 2021	Substantially Equivalent	Medacta International SA
K210136	PhantomMSK Hip	Feb 18, 2021	Substantially Equivalent	OrthoGrid Systems, Inc
K203312	Vitrea Software Package, VSTP-001A	Feb 16, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K203103	Synapse 3D, Synapse 3D Base Tools v6.1	Feb 09, 2021	Substantially Equivalent	Fujifilm Corporation
K203290	Bonelogic	Feb 05, 2021	Substantially Equivalent	Disior Ltd
K203582	QUIBIM Precision Prostate (qp-Prostate)	Feb 04, 2021	Substantially Equivalent	QUIBIM S.L.
K203104	IBM iConnect Access	Jan 26, 2021	Substantially Equivalent	Merge Healthcare Incorporated
K203677	ViewPoint 6	Jan 15, 2021	Substantially Equivalent	GE Medical Systems Ultrasound & Primary Care Diagnostics,LLC
K203142	Veuron-Brain-pAb	Jan 15, 2021	Substantially Equivalent	Heuron Co., Ltd.
K202847	AccuBrain	Jan 15, 2021	Substantially Equivalent	BrainNow Medical Technology Limited
K202414	BrainInsight	Jan 07, 2021	Substantially Equivalent	Hyperfine Research, Inc
K202229	AI Metrics	Dec 22, 2020	Substantially Equivalent	AI Metrics, LLC
K201250	SQuEEZ Software	Dec 18, 2020	Substantially Equivalent	Cardiowise, Inc.
K203249	Nucleus.io	Dec 04, 2020	Substantially Equivalent	NucleusHealth, LLC
K202487	HealthJOINT	Dec 04, 2020	Substantially Equivalent	Zebra Medical Vision Ltd.
K200572	Planmeca Romexis	Dec 02, 2020	Substantially Equivalent	Planmeca Oy
K203156	DTX Studio Clinic	Nov 20, 2020	Substantially Equivalent	Nobel Biocare AB
K202805	Optimized Positioning System (OPS) Insight	Nov 20, 2020	Substantially Equivalent	Corin USA
K193287	CorInsights MRI	Nov 20, 2020	Substantially Equivalent	ADM Diagnostics, Inc.
K203287	DBSWIN, VISTAEASY	Nov 18, 2020	Substantially Equivalent	Dürr Dental SE
K193306	PROView	Nov 17, 2020	Substantially Equivalent	GE Medical Systems SCS
K200750	Neuro.Al Algorithm	Nov 06, 2020	Substantially Equivalent	TeraRecon, Inc.
K200350	MyHip Planner & Verifier	Nov 04, 2020	Substantially Equivalent	Medacta International SA
K203058	CloudVue	Oct 29, 2020	Substantially Equivalent	International Medical Solutions Inc.
K202519	OrthoNext Platform System	Oct 27, 2020	Substantially Equivalent	Orthofix Srl
K202948	EzOrtho	Oct 22, 2020	Substantially Equivalent	Ewoo Soft Co., Ltd.
K201710	A View LCS	Oct 16, 2020	Substantially Equivalent	Coreline Soft Co., Ltd.
K202501	Quantib Prostate	Oct 11, 2020	Substantially Equivalent	Quantib BV
K200810	IPS CaseDesigner	Oct 08, 2020	Substantially Equivalent	Nobel Biocare AB
K202292	UDE	Oct 05, 2020	Substantially Equivalent	EBM Technologies Inc.
K202280	Cleerly Labs v2.0	Oct 02, 2020	Substantially Equivalent	Cleerly, Inc.
K201928	e-Ortho Shoulder Software	Sep 30, 2020	Substantially Equivalent	FH Industrie
K192051	THINQ	Sep 30, 2020	Substantially Equivalent	CorticoMetrics LLC
K201103	Xeleris V Processing and Review Systems	Sep 25, 2020	Substantially Equivalent	GE Healthcare
K200603	AAA Model	Sep 20, 2020	Substantially Equivalent	Philips Ultrasound, Inc
K200852	EchoPAC Software Only, EchoPAC Plug-In	Sep 18, 2020	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics
K192890	SentEP	Sep 18, 2020	Substantially Equivalent	SentiAR, Inc
K201369	AVA (Augmented Vascular Analysis)	Sep 16, 2020	Substantially Equivalent	See-Mode Technologies Pte. Ltd.
K201665	Collaboration Live	Sep 15, 2020	Substantially Equivalent	Philips Ultrasound, Inc.
K202297	Aline Ablation Intelligence	Sep 11, 2020	Substantially Equivalent	Mirada Medical Ltd
K202256	3Shape Implant Studio	Sep 09, 2020	Substantially Equivalent	3Shape Medical A/S
K201948	AcroDTI Visualizer	Sep 09, 2020	Substantially Equivalent	AcroViz Inc.
K202335	Ambra ProViewer	Sep 04, 2020	Substantially Equivalent	Dicom Grid, Inc, dba Ambra Health
K200973	Synapse 3D Cardiac Tools	Aug 27, 2020	Substantially Equivalent	FUJIFILM Corporaton
K200714	AVIEW	Aug 26, 2020	Substantially Equivalent	Coreline Soft Co., Ltd
K202116	EzDent-i/ E2/ Prora View/ Smart M Viewer	Aug 21, 2020	Substantially Equivalent	Ewoo soft Co., Ltd.
K201352	3D Auto LAA	Aug 17, 2020	Substantially Equivalent	Philips Healthcare
K201632	TOMTEC-ARENA	Aug 14, 2020	Substantially Equivalent	TOMTEC Imaging Systems GmbH
K201232	Limbus Contour	Aug 13, 2020	Substantially Equivalent	Limbus AI Inc.
K200822	Braid	Aug 13, 2020	Substantially Equivalent	Braid.Health
K201465	SuRgical Planner (SRP) BrainStorm	Jul 17, 2020	Substantially Equivalent	Surgical Theater, Inc.
K201365	True 3D Viewer	Jul 17, 2020	Substantially Equivalent	EchoPixel, Inc.
K193294	AI-Rad Companion Engine	Jul 10, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K201296	i-Rapha Solution	Jul 09, 2020	Substantially Equivalent	IRM Inc
K201477	syngo.via View&GO	Jul 01, 2020	Substantially Equivalent	Siemens Healthcare GmbH
K193042	Optimized Positioning System (OPS) ReView	Jun 26, 2020	Substantially Equivalent	Corin USA
K193290	AI-Rad Companion Brain MR	Jun 17, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K200899	Quantib AI Node	Jun 15, 2020	Substantially Equivalent	Quantib BV
K192630	uWS-MI	Jun 11, 2020	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K201202	MI View&GO	Jun 02, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K192692	Brainomix 360 e-CTA	May 28, 2020	Substantially Equivalent	Brainomix Limited
K200274	CariCloud	May 21, 2020	Substantially Equivalent	Caristo Diagnostics
K201062	syngo Ultrasound Apps Suite (sUSAS)	May 18, 2020	Substantially Equivalent	Siemens Medical Solutions, USA, Inc.
K200546	ZeeroMED View	May 05, 2020	Substantially Equivalent	O3 Enterprise SRL
K200315	Ziostation2	May 05, 2020	Substantially Equivalent	Ziosoft, Inc.
K193220	AVIEW LCS	May 05, 2020	Substantially Equivalent	Coreline Soft Co., Ltd
K192656	Optimized Positioning System (OPS) Insight	May 01, 2020	Substantially Equivalent	Corin USA
K193523	ArthrexVIP Web Portal	Apr 30, 2020	Substantially Equivalent	Arthrex Inc.
K192475	NemoFAB	Apr 23, 2020	Substantially Equivalent	Software Nemotec S.L.
K200703	JiveX	Apr 14, 2020	Substantially Equivalent	Visus Health IT GmbH
K193369	Xelis Dental 2.0	Apr 14, 2020	Substantially Equivalent	Infinitt Healthcare Co.,Ltd.
K200078	VARO Plan	Apr 10, 2020	Substantially Equivalent	3D Industrial Imaging Co., Ltd.
K200713	EchoNavigator	Apr 09, 2020	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K192176	IntelePACS	Apr 02, 2020	Substantially Equivalent	Intelerad Medical Systems Incorporated
K190767	AnatomicAligner	Mar 16, 2020	Substantially Equivalent	The Methodist Hospital Research Institute d/b/a Houston
K192888	EzOrtho	Mar 13, 2020	Substantially Equivalent	Ewoo Soft Co., Ltd.
K190993	Kinepict Medical Imaging Tool version v2.2	Mar 05, 2020	Substantially Equivalent	Kinepict Health Ltd
K192962	icobrain-ctp	Feb 28, 2020	Substantially Equivalent	Icometrix NV
K200178	Ez3D-i /E3	Feb 25, 2020	Substantially Equivalent	Ewoosoft Co., Ltd.
K192973	densitas densityai	Feb 19, 2020	Substantially Equivalent	Densitas, Inc.
K200179	Collaboration Live	Feb 18, 2020	Substantially Equivalent	Philips Healthcare
K200132	Ashvins	Feb 18, 2020	Substantially Equivalent	MedicalCommunications GmbH
K192923	Vitrea Software Package	Feb 14, 2020	Substantially Equivalent	Canon Medical Systems Corporation
K192372	ASCEND Image Viewer	Feb 14, 2020	Substantially Equivalent	Ascend Hit
K193498	Infinitt RT PACS	Feb 13, 2020	Substantially Equivalent	Infinitt Healthcare Co.,Ltd.
K192165	Acteon Imaging Suite	Feb 11, 2020	Substantially Equivalent	de Gotzen S.R.L
K192462	syngo.MR Applications	Jan 31, 2020	Substantially Equivalent	Siemens Medical Solutions USA Inc.
K193261	FlightPlan for Embolization	Jan 24, 2020	Substantially Equivalent	GE Medical Systems SCS
K191014	Elements Viewer	Jan 23, 2020	Substantially Equivalent	Brainlab AG
K192098	EzMobile	Jan 20, 2020	Substantially Equivalent	Ewoosoft Co., Ltd.
K191125	ADAS 3D	Jan 15, 2020	Substantially Equivalent	Galgo Medical S.L
K192917	ViewPoint 6	Jan 06, 2020	Substantially Equivalent	GE Medical Systems Ultrasound and
K192912	AutoMIStar	Dec 31, 2019	Substantially Equivalent	Apollo Medical Imaging Technology Pty. Ltd.
K193403	UroNav System	Dec 27, 2019	Substantially Equivalent	Invivo Corporation
K193149	True 3D Viewer Software	Dec 27, 2019	Substantially Equivalent	EchoPixel Inc.
K192040	AVIEW Modeler	Dec 20, 2019	Substantially Equivalent	Coreline Soft Co., Ltd
K183676	DentiqAir	Dec 19, 2019	Substantially Equivalent	3D Industrial Imaging Co., Ltd.
K192531	QyScore Software	Dec 13, 2019	Substantially Equivalent	Qynapse
K192130	Icobrain	Dec 13, 2019	Substantially Equivalent	Icometrix NV
K192571	NemoScan	Dec 11, 2019	Substantially Equivalent	Software Nemotec S.L.
K192279	PhantomMSK Trauma	Dec 07, 2019	Substantially Equivalent	OrthoGrid Systems Inc.
K192348	SICAT Implant V2.0	Dec 04, 2019	Substantially Equivalent	SICAT GmbH & Co. KG
K192038	Emprint Visualization Application	Dec 02, 2019	Substantially Equivalent	Covidien LLC.
K192508	Medsynapse Ris Pacs & Medsynapse VNA	Nov 22, 2019	Substantially Equivalent	Medsynaptic Private Ltd
K191278	RSI-MRI+	Nov 19, 2019	Substantially Equivalent	MultiModal Imaging Services Corporation (dba HealthLytix)
K191959	QuantX Breast MRI Biopsy Guidance Plugin	Nov 08, 2019	Substantially Equivalent	Qlarity Imaging
K191026	MEDIP PRO	Nov 07, 2019	Substantially Equivalent	MEDICALIP Co., Ltd
K192109	KOALA	Nov 05, 2019	Substantially Equivalent	IB Lab GmbH
K190868	Cleerly Labs	Nov 05, 2019	Substantially Equivalent	Cleerly Inc
K192743	VisionX 2.4	Oct 31, 2019	Substantially Equivalent	Durr Dental SE
K183412	mediCAD Web	Oct 31, 2019	Substantially Equivalent	mediCAD Hectec GmbH
K191544	Synapse 3D Blood Flow Analysis	Oct 18, 2019	Substantially Equivalent	Fujifilm Corporation
K192455	Merge PACS	Oct 17, 2019	Substantially Equivalent	Merge Healthcare Incorporated
K191216	Voxel Dosimetry v1.0	Oct 17, 2019	Substantially Equivalent	Hermes Medical Solutions AB
K190162	SmartCeph	Oct 17, 2019	Substantially Equivalent	Ortho2, LLC
K191493	Ventripoint Medical System Plus (VMS+) 3.0	Oct 16, 2019	Substantially Equivalent	Ventripoint Diagnostics, Ltd.
K192200	DynaCAD	Oct 09, 2019	Substantially Equivalent	Invivo Corporation
K191610	RTapp	Oct 01, 2019	Substantially Equivalent	SegAna, LLC
K192435	NuVasive NuvaLine	Sep 26, 2019	Substantially Equivalent	NuVasive, Incorporated
K191530	StoneChecker	Sep 26, 2019	Substantially Equivalent	Imaging Biometrics, LLC
K192276	Merge Cardio	Sep 20, 2019	Substantially Equivalent	Merge Healthcare Incorporated
K191688	SubtleMR	Sep 16, 2019	Substantially Equivalent	Subtle Medical, Inc.
K192304	SIS Software Version 3.6.0	Sep 13, 2019	Substantially Equivalent	Surgical Information Sciences, Inc.
K190780	syngo Application Software	Sep 12, 2019	Substantially Equivalent	Siemens Medical Solution USA, Inc.
K183489	D2P	Aug 29, 2019	Substantially Equivalent	3D Systems, Inc.
K183544	Efficient Care 3D Planning	Aug 23, 2019	Substantially Equivalent	Orthosoft, Inc. (d/b/a Zimmer CAS)
K183458	exoplan 2.3	Aug 06, 2019	Substantially Equivalent	exocad GmbH
K191262	aBSI	Aug 05, 2019	Substantially Equivalent	EXINI Diagnostics AB
K183193	MREplus+ Software	Aug 01, 2019	Substantially Equivalent	Resoundant Inc
K191309	syngo.via MI Workflows VB40A, Scenium	Jul 19, 2019	Substantially Equivalent	Siemens Medical Soultions USA, Inc.
K191585	iNtuition-Structural Heart Module	Jul 12, 2019	Substantially Equivalent	TeraRecon Inc.
K190694	Unifi Workspace v1.0.0	Jul 11, 2019	Substantially Equivalent	Hologic, Inc.
K182904	syngo.MR Applications	Jul 05, 2019	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K190096	R2GATE	Jun 26, 2019	Substantially Equivalent	MegaGen Implant Co., Ltd.
K183170	uWS-CT	Jun 24, 2019	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K190913	QLAB Advanced Quantification Software 13	Jun 18, 2019	Substantially Equivalent	Philips Healthcare
K183460	ClariCT.AI	Jun 13, 2019	Substantially Equivalent	ClariPI Inc.
K190874	Materialise Mimics Enlight	Jun 05, 2019	Substantially Equivalent	Materialise N.V.
K191188	ASHK100G	May 30, 2019	Substantially Equivalent	LG Electronics
K191040	syngo.via (Version VB40A)	May 16, 2019	Substantially Equivalent	Siemens Healthcare GmbH
K190764	SurgicalAR	May 13, 2019	Substantially Equivalent	MEDIVIS, Inc.
K190866	XmaruView V1 (Xmaru Chiroview, Xmaru Podview)	Apr 30, 2019	Substantially Equivalent	Rayence Co., Ltd
K190042	Brainlab Elements Image Fusion Angio	Apr 25, 2019	Substantially Equivalent	Brainlab AG
K183248	Synapse Enterprise Viewer Version 1.0	Apr 25, 2019	Substantially Equivalent	FUJIFILM Corporation
K190791	Ez3D-i/E3	Apr 19, 2019	Substantially Equivalent	EwooSoft Co., Ltd.
K183593	Lung Vision System	Apr 18, 2019	Substantially Equivalent	Body Vision Medical Ltd.
K190420	NDOHD High Definition Imaging System (NDOHD)	Apr 15, 2019	Substantially Equivalent	Altaravision Inc.
K182572	InstaRISPACS / InstaZFP / InstaMobi v5.0	Apr 12, 2019	Substantially Equivalent	Meddiff Technologies Pvt. Ltd.
K190629	DBSWIN and VISTAEASY Imaging Software	Apr 01, 2019	Substantially Equivalent	Durr Dental SE
K183210	Thoracic VCAR with GSI Pulmonary Perfusion	Mar 29, 2019	Substantially Equivalent	GE Medical Systems SCS
K183105	Mimics Medical	Mar 27, 2019	Substantially Equivalent	Materialise NV
K190232	Synapse PACS	Mar 26, 2019	Substantially Equivalent	FUJIFILM Corporation
K183164	uWS-MR	Mar 22, 2019	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K190379	MIM on Linux	Mar 19, 2019	Substantially Equivalent	MIM Software Inc.
K183019	SIS Software version 3.3.0	Mar 19, 2019	Substantially Equivalent	Surgical Information Sciences, Inc.
K182537	RADMAX Digital Imaging Software	Mar 08, 2019	Substantially Equivalent	DRGEM Corporation
K182966	PLANET Onco Dose	Mar 06, 2019	Substantially Equivalent	DOSIsoft
K181859	Visualase Thermal Therapy System	Mar 06, 2019	Substantially Equivalent	Medtronic Navigation Inc.
K183478	ClearON Mobile	Mar 01, 2019	Substantially Equivalent	Rayence Co.,Ltd
K190087	EzDent-i / E2 / Prora View	Feb 27, 2019	Substantially Equivalent	EWOO SOFT Co., Ltd.
K182643	IRIS 1.0 System	Feb 22, 2019	Substantially Equivalent	Intuitive Surgical
K182332	PhantomMSK	Feb 15, 2019	Substantially Equivalent	OrthoGrid Systems Inc.
K190074	Presero 3D Scanning System	Feb 14, 2019	Substantially Equivalent	Certis Health
K183272	AI Rad Companion (Engine)	Feb 01, 2019	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K183133	MRCP+ v1.0	Jan 09, 2019	Substantially Equivalent	Perspectum Diagnostics Ltd
K182855	ProKnow DS	Jan 02, 2019	Substantially Equivalent	ProKnow LLC
K180867	AmCAD-UO	Dec 28, 2018	Substantially Equivalent	AmCad BioMed Corporation
K182564	Quantib ND	Dec 27, 2018	Substantially Equivalent	Quantib BV
K182130	iSchemaView RAPID	Dec 27, 2018	Substantially Equivalent	iSchemaView, Inc.
K183012	vascuCAP	Dec 21, 2018	Substantially Equivalent	Elucid Bioimaging Inc.
K182750	4D View	Dec 21, 2018	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics,
K173041	3DIEMME RealGUIDE	Dec 20, 2018	Substantially Equivalent	3DIEMME Ltd.
K182624	MIM - MRT Dosimetry	Dec 18, 2018	Substantially Equivalent	MIM Software Inc.
K182601	Vitrea Software Package, VSTP-001A	Dec 14, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K182419	Centricity Universal Viewer	Dec 14, 2018	Substantially Equivalent	GE Healthcare
K182359	HipCheck	Dec 13, 2018	Substantially Equivalent	Stryker Corp.
K182926	IntelliSpace Radiology	Dec 06, 2018	Substantially Equivalent	Philips Healthcare Informatics, Inc.
K182016	Simplicit90Y	Dec 06, 2018	Substantially Equivalent	Mirada Medical Ltd.
K181825	CAAS MR Solutions	Dec 04, 2018	Substantially Equivalent	Pie Medical Imaging B.V.
K173083	IMPLANTER DENTAL PLANNING SOFTWARE	Dec 03, 2018	Substantially Equivalent	Implanter LLC
K182815	XVWeb 3D	Nov 30, 2018	Substantially Equivalent	Apteryx, Inc.
K183038	Corin Optimized Positioning System (OPS) Plan	Nov 26, 2018	Substantially Equivalent	Corin USA
K183013	Vitrea Software Package, VSTP-001A	Nov 26, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K182431	Konicaminolta DI-X1	Nov 26, 2018	Substantially Equivalent	Konica Minolta, Inc.
K173744	ProFuse CAD	Nov 21, 2018	Substantially Equivalent	Eigen
K181247	Vitrea CT Brain Perfusion	Nov 20, 2018	Substantially Equivalent	Vital Images, Inc.
K173001	uWS-CT	Nov 07, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co.,Ltd.
K172999	uWS-MR	Nov 07, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co.,Ltd.
K181939	icobrain	Nov 06, 2018	Substantially Equivalent	icometrix NV
K171199	AVIEW	Oct 31, 2018	Substantially Equivalent	Coreline Soft Co., Ltd.
K173965	Implant Planning Software	Oct 26, 2018	Substantially Equivalent	Inteware Co. Ltd.
K182464	PeekMed	Oct 25, 2018	Substantially Equivalent	Peek Health, S.A.
K181964	JiveX	Oct 23, 2018	Substantially Equivalent	Visus Health IT GmbH
K182561	UroNav (Version 3.0)	Oct 19, 2018	Substantially Equivalent	Invivo Corporation
K182034	Arterys MICA	Oct 17, 2018	Substantially Equivalent	Arterys Inc.
K181460	OnePacs System	Oct 11, 2018	Substantially Equivalent	OnePacs, LLC
K181892	Ziostation2	Oct 09, 2018	Substantially Equivalent	Ziosoft, Inc.
K182290	IBM iConnect Access	Sep 25, 2018	Substantially Equivalent	Merge Healthcare Incorporated
K181773	Synapse 3D Optional Tools	Sep 25, 2018	Substantially Equivalent	FUJIFILM Corporation
K180916	iNtuition-T1 Mapping and T2/T2* Mapping	Sep 24, 2018	Substantially Equivalent	TeraRecon Inc.,
K182310	Volpara Imaging Software	Sep 21, 2018	Substantially Equivalent	Volpara Health Technologies Limited
K181926	InVivo Web Viewer	Sep 21, 2018	Substantially Equivalent	Anatomage Inc.
K172418	OpenSight	Sep 21, 2018	Substantially Equivalent	Novarad Corporation
K182230	Multi Modality Viewer	Sep 07, 2018	Substantially Equivalent	Vital Images, Inc.
K182208	syngo.via View&GO (Version VA10A)	Sep 07, 2018	Substantially Equivalent	Siemens Healthcare GmbH
K170702	mediCAD 4.0	Sep 07, 2018	Substantially Equivalent	mediCAD Hectec Gmbh
K180006	AmCAD-UT Detection 2.2	Aug 31, 2018	Substantially Equivalent	AmCad BioMed Corporation
K181185	Change Healthcare Enterprise Viewer	Aug 29, 2018	Substantially Equivalent	Change Healthcare Canada Company
K180522	IGTFusion	Aug 16, 2018	Substantially Equivalent	IGI Technologies
K181318	ONIS-PACS	Aug 13, 2018	Substantially Equivalent	DigitalCore Co., Ltd
K181962	CubeVue	Aug 07, 2018	Substantially Equivalent	CurveBeam, LLC
K171435	VirtuOst Vertebral Fracture Assessment	Aug 03, 2018	Substantially Equivalent	O.N. Diagnostics, LLC.
K171977	miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer	Aug 02, 2018	Substantially Equivalent	Hinacom Software and Technology, Ltd
K173444	Quantitative Total Extensible Imaging (QTxI)	Jul 23, 2018	Substantially Equivalent	AIQ Solutions, Inc.
K180629	DentiqGuide	Jul 19, 2018	Substantially Equivalent	3D Industrial Imaging Co., Ltd
K173274	Ceevra Reveal 2.0	Jul 10, 2018	Substantially Equivalent	Ceevra, Inc.
K173574	DenSeeMammo	Jun 26, 2018	Substantially Equivalent	Statlife
K180815	MIM - SPECTRA Quant	Jun 22, 2018	Substantially Equivalent	MIM Software Inc.
K172346	sterEOS Workstation	Jun 19, 2018	Substantially Equivalent	EOS imaging
K181290	Fusion Bx 2.0	Jun 15, 2018	Substantially Equivalent	Focal Healthcare Inc.
K173780	EchoMD Automated Ejection Fraction Software	Jun 14, 2018	Substantially Equivalent	Bay Labs, Inc.
K181264	QLAB Advanced Quantification Software	Jun 07, 2018	Substantially Equivalent	Philips Ultrasound Inc.
K181177	Interventional Workspot	May 31, 2018	Substantially Equivalent	Philips Medical Systems Nederland BV
K181080	McKesson Cardiology	May 24, 2018	Substantially Equivalent	Change Healthcare Israel Ltd.
K180883	5D Viewer	May 15, 2018	Substantially Equivalent	Samsung Medison Co., Ltd.
K180641	Invenia ABUS Viewer	May 04, 2018	Substantially Equivalent	GE Healthcare
K173390	hipEOS	Apr 27, 2018	Substantially Equivalent	oneFIT Medical
K180563	syngo.plaza	Apr 25, 2018	Substantially Equivalent	Siemens Healthcare GmbH
K172768	ZOOM	Apr 24, 2018	Substantially Equivalent	Zetta Medical Technologies, LLC.
K180161	Viz CTP	Apr 20, 2018	Substantially Equivalent	Viz.ai, Inc.
K180336	syngo.MR Applications	Apr 19, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K172477	iSchemaView RAPID	Apr 19, 2018	Substantially Equivalent	iSchemaView, Inc.
K180549	ZED Link	Apr 12, 2018	Substantially Equivalent	Zed Technologies
K180125	PowerLook Density Assessment Software	Apr 05, 2018	Substantially Equivalent	iCAD, Inc
K173897	syngo.via MI Workflows	Apr 05, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K172998	uWS-MI	Apr 05, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co.,Ltd.
K171847	Corin Optimized Positioning System (OPS) Plan	Apr 05, 2018	Substantially Equivalent	Corin USA Limited
K173597	Scenium VE20 Software	Apr 04, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K172239	SIMPLANT 18	Apr 04, 2018	Substantially Equivalent	Dentsply Sirona
K180323	Vitrea Software Package; VSTP-001A	Mar 30, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K173241	MED-TAB	Mar 23, 2018	Substantially Equivalent	PLUM Medical Solutions GmbH
K180192	Emprint Ablation Visualization Application	Mar 21, 2018	Substantially Equivalent	Covidien, LLC
K173619	Mimics inPrint	Mar 21, 2018	Substantially Equivalent	Materialise NV
K172168	WillCeph	Mar 21, 2018	Substantially Equivalent	HDX WILL CORP.
K180129	Imbio Segmentation Editing Tool software	Mar 16, 2018	Substantially Equivalent	Imbio, LLC
K173611	syngo Application Software	Mar 16, 2018	Substantially Equivalent	Siemens Medical Solutions, USA Inc.
K180262	SICAT Endo	Mar 12, 2018	Substantially Equivalent	SICAT GmbH & Co. KG
K180394	BrightMatter Plan 1.6.0	Mar 09, 2018	Substantially Equivalent	Synaptive Medical Inc.
K173939	Quantib Brain	Mar 09, 2018	Substantially Equivalent	Quantib BV
K180326	icobrain	Mar 08, 2018	Substantially Equivalent	icometrix
K173605	iQMR	Mar 08, 2018	Substantially Equivalent	Medic Vision - Imaging Solutions Ltd
K173312	ProBx Software	Mar 02, 2018	Substantially Equivalent	Harmonus Inc.
K173145	CereMetrix Silver	Feb 28, 2018	Substantially Equivalent	CereMetrix Corp
K173863	Ez3D-i /E3	Feb 23, 2018	Substantially Equivalent	Ewoo Soft Co., Ltd.
K170540	DM-Density	Feb 23, 2018	Substantially Equivalent	Densitas, Inc.
K173636	Velocity	Feb 15, 2018	Substantially Equivalent	Varian Medical Systems, Inc.
K170793	SuRgical Planner (SRP)	Feb 12, 2018	Substantially Equivalent	Surgical Theater, LLC
K180091	UNiD Spine Analyzer	Feb 08, 2018	Substantially Equivalent	Medicrea International
K162727	SENYINT Remote Consultation System	Feb 08, 2018	Substantially Equivalent	Dalian Senyint Digital Medical System Co., Ltd.
K172832	Insight BD	Feb 06, 2018	Substantially Equivalent	Siemens Medical Solutions, Inc
K172490	eUnity	Feb 06, 2018	Substantially Equivalent	Client Outlook Inc.
K173512	MFI-Cardiac	Feb 05, 2018	Substantially Equivalent	MultiFunctional Imaging, LLC
K173088	Vitrea Software Toshiba Package VSTP-001A	Jan 31, 2018	Substantially Equivalent	Toshiba Medical Systems Corporation
K173542	Arterys Oncology DL	Jan 25, 2018	Substantially Equivalent	Arterys Inc.
K173622	CS Imaging	Jan 16, 2018	Substantially Equivalent	Trophy
K173054	Navigo Workstation Version 2.0	Jan 16, 2018	Substantially Equivalent	UC-Care Ltd.
K173588	Illumeo System	Jan 12, 2018	Substantially Equivalent	Philips Medical Systems Technologies, Ltd.
K172224	DTX Studio diagnose	Jan 11, 2018	Substantially Equivalent	Nobel Biocare AB
K171328	cNeuro cMRI	Jan 08, 2018	Substantially Equivalent	Combinostics Oy
K173456	ViewPoint 6	Jan 05, 2018	Substantially Equivalent	GE Medical Systems Ultrasound and Primary
K173420	Radiomics App v1.0	Dec 27, 2017	Substantially Equivalent	Microsoft Corp.
K173467	Advanced Diffusion Analysis (ADA) application	Dec 12, 2017	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K173475	Merge PACS	Dec 08, 2017	Substantially Equivalent	Merge Healthcare Incorporated
K172218	MIM Y90 Dosimetry	Nov 21, 2017	Substantially Equivalent	MIM Software Inc.
K173378	syngo®.via protoNeo (Version VA20)	Nov 20, 2017	Substantially Equivalent	Siemens Healthcare GmbH
K173329	jFit Surgical Planner	Nov 15, 2017	Substantially Equivalent	JointVue LLC
K171385	Planmeca Romexis	Nov 14, 2017	Substantially Equivalent	Planmeca Oy
K173247	Surgical Planning Software version 1.1	Nov 08, 2017	Substantially Equivalent	Ortho Kinematics, Inc
K172803	Infinitt PACS 7.0	Oct 27, 2017	Substantially Equivalent	Infinitt Healthcare Co.,Ltd.
K173094	OrthoVision	Oct 26, 2017	Substantially Equivalent	Ewoo Soft Co., Ltd.
K171709	BR-FHUS Viewer 1.0	Oct 20, 2017	Substantially Equivalent	TaiHao Medical Inc.
K163623	Quantra	Oct 20, 2017	Substantially Equivalent	HOLOGIC, INC.
K173101	Curve Image 2.0 PACS	Oct 18, 2017	Substantially Equivalent	Curve Dental LTD
K171068	OrthoView 7.2	Oct 18, 2017	Substantially Equivalent	Meridian Technique Ltd
K172855	Vitrea Advanced Visualization, Version 7.6	Oct 05, 2017	Substantially Equivalent	Vital Images, Inc.
K171463	ASPIRE Bellus II	Sep 29, 2017	Substantially Equivalent	FUJIFILM Medical Systems U.S.A., Inc.
K170816	Elements Image Fusion, Elements Cranial Distortion Correction, Elements Spine Curvature Correction, Elements TRAM	Sep 26, 2017	Substantially Equivalent	Brainlab AG
K172513	3D Echo	Sep 14, 2017	Substantially Equivalent	JointVue LLC
K170981	NeuroQuant	Sep 07, 2017	Substantially Equivalent	CorTechs Labs, Inc
K172327	VMA System version 3.0	Aug 25, 2017	Substantially Equivalent	Ortho Kinematics, Inc.
K172364	EzDent-i / E2 / Prora View	Aug 22, 2017	Substantially Equivalent	Ewoo Soft Co., Ltd.
K171617	OKI Surgical Planning Software	Aug 22, 2017	Substantially Equivalent	Ortho Kinematics, Inc.
K171356	Clarity Reveal	Aug 03, 2017	Substantially Equivalent	Ceevra, Inc.
K171754	NovaPACS	Jul 28, 2017	Substantially Equivalent	Novarad Corporation
K163048	Smart Stitching Software System, Image Processing, Radiological	Jul 28, 2017	Substantially Equivalent	OSKO, INC.
K170841	BiopSee, Mobile US	Jul 26, 2017	Substantially Equivalent	MedCom GmbH
K163232	Vitrea View	Jul 21, 2017	Substantially Equivalent	Vital Images, Inc
K171544	Arterys Viewer	Jul 18, 2017	Substantially Equivalent	Arterys Inc.
K170729	Examion X-AQS	Jul 18, 2017	Substantially Equivalent	Examion GmbH
K171115	3D Endo Software	Jul 17, 2017	Substantially Equivalent	Dentsply Sirona
K170434	Enterprise Imaging XERO Viewer 8.1	Jul 03, 2017	Substantially Equivalent	Agfa HealthCare N.V.
K163668	SUITESTENSA	Jun 23, 2017	Substantially Equivalent	EBIT srl
K170847	EchoPAC Software Only, EchoPAC Plug-in	Jun 14, 2017	Substantially Equivalent	GE Medical Systems Ultrasound and Primary Care Diagnostics
K170747	syngo Application Software	Jun 09, 2017	Substantially Equivalent	Siemens Medical Solutions, USA, Inc.
K171222	Vitrea Software Toshiba Package; VSTP-001A	Jun 08, 2017	Substantially Equivalent	Toshiba Medical Systems Corporation
K170250	SmartTarget	Jun 07, 2017	Substantially Equivalent	SmartTarget, Ltd.
K171053	syngo Dynamics Version VA30	Jun 01, 2017	Substantially Equivalent	Siemens Healthcare GmbH
K171314	QLAB Advanced Quantification Software	May 30, 2017	Substantially Equivalent	Philips Healthcare
K162574	AmCAD-US	May 30, 2017	Substantially Equivalent	AmCad BioMed Corporation
K170172	UNiD Spine Analyzer	May 24, 2017	Substantially Equivalent	MEDICREA INTERNATIONAL
K163071	vascuCAP	May 24, 2017	Substantially Equivalent	Elucid Bioimaging, Inc.
K170195	QuantX	May 17, 2017	Substantially Equivalent	Quantitative Insights, Inc.
K161601	Dynamika	May 17, 2017	Substantially Equivalent	IMAGE ANALYSIS LIMITED
K170419	SurgiCase Viewer	May 11, 2017	Substantially Equivalent	Materialise NV
K163622	Lung Vision	May 11, 2017	Substantially Equivalent	BODY VISION MEDICAL LTD.
K163250	Longitudinal Brain Imaging (LoBI) application	May 11, 2017	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K170180	Will3D	May 08, 2017	Substantially Equivalent	HDX WILL CORP.
K171130	Nucleus Image Management System	May 04, 2017	Substantially Equivalent	NucleusHealth, LLC
K163119	NaviSuite SSI Edition	May 01, 2017	Substantially Equivalent	MEDCOM GMBH
K162647	NuVasive NuvaLine Mobile App	May 01, 2017	Substantially Equivalent	NUVASIVE, INCORPORATED
K170952	syngo.CT View&GO	Apr 28, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K170069	AmCAD-UV	Apr 26, 2017	Substantially Equivalent	AmCad BioMed Corporation
K162799	Cliniview	Apr 25, 2017	Substantially Equivalent	Palodex Group Oy
K170580	Carestream Vue PACS	Apr 11, 2017	Substantially Equivalent	Carestream Health, Inc.
K162287	Synapse 3D Perfusion Analysis	Apr 06, 2017	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K163076	Segment CMR	Apr 05, 2017	Substantially Equivalent	MEDVISO AB
K161341	LIFESYS PACS	Apr 05, 2017	Substantially Equivalent	LIFETRACK MEDICAL SYSTEMS, INC.
K162559	Move Forward 3D Motion Simulation Service	Mar 31, 2017	Substantially Equivalent	BIOMET INC.
K163290	INFINITT ULite	Mar 24, 2017	Substantially Equivalent	INFINITT CO., LTD.
K163405	360KS Implant Positioning System	Mar 21, 2017	Substantially Equivalent	Kico Knee Innovation Company PTY Limited
K162868	Exam Vue PACS	Mar 17, 2017	Substantially Equivalent	JPI Healthcare Solutions, Inc
K170451	FDX Console (DR-ID300CL) Software	Mar 16, 2017	Substantially Equivalent	FUJIFILM Medical Systems U.S.A., Inc.
K170167	True 3D Viewer Software	Mar 03, 2017	Substantially Equivalent	EchoPixel Inc.
K162484	Lung Nodule Assessment and Comparison Option (LNA)	Feb 23, 2017	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K163285	syngo Application Software	Feb 14, 2017	Substantially Equivalent	SIEMENS MEDICAL SOLUTION USA, INC.
K162830	SIS Software	Feb 14, 2017	Substantially Equivalent	Surgical Information Sciences, Inc.
K163294	syngo.MR General, syngo.MR Cardiology, syngo.MR Neurology	Feb 06, 2017	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K160934	UC-CARE NaviGo Workstation	Feb 06, 2017	Substantially Equivalent	UC-CARE LTD.
K163122	NobelClinician, DTX Studio implant	Jan 31, 2017	Substantially Equivalent	NOBEL BIOCARE AB
K163324	nordicBrainEx	Jan 27, 2017	Substantially Equivalent	NordicNeurolab AS
K162285	EBM iDO Viewer 1.2.1	Jan 27, 2017	Substantially Equivalent	EBM Technologies Incorporated
K163574	Multi Modality Viewer	Jan 26, 2017	Substantially Equivalent	Vital Images, Inc.
K163533	EzDent-i; E2; ProraView	Jan 12, 2017	Substantially Equivalent	EWOO SOFT CO., LTD.
K161841	D2P	Jan 09, 2017	Substantially Equivalent	3D SYSTEMS, INC.
K163013	Quantib Brain 1.2	Jan 06, 2017	Substantially Equivalent	Quantib BV
K163253	Arterys Cardio DL	Jan 05, 2017	Substantially Equivalent	ARTERYS INC.
K161270	CephSimulation	Jan 04, 2017	Substantially Equivalent	ANATOMAGE, INC
K163421	syngo.via MI Workflows	Jan 03, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K161959	ClearView cCAD	Dec 28, 2016	Substantially Equivalent	ClearView Diagnostics Inc.
K163539	Ez3D-i / E3	Dec 23, 2016	Substantially Equivalent	EWOO SOFT Co., Ltd.
K162955	Multi-Modality Tumor Tracking (MMTT) application	Dec 19, 2016	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K160852	Zia	Dec 15, 2016	Substantially Equivalent	Zetta Medical Technologies, LLC.
K162376	CAAS MR 4D Flow	Dec 08, 2016	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K161322	CT CoPilot	Dec 07, 2016	Substantially Equivalent	ZEPMED, LLC.
K152009	DENSEEMAMMO v1.0	Dec 05, 2016	Substantially Equivalent	STATLIFE
K163158	MEDSYNAPSE Zero Footprint Viewer	Dec 02, 2016	Substantially Equivalent	MEDSYNAPTIC PRIVATE LTD.
K162743	ViewPoint 6	Nov 22, 2016	Substantially Equivalent	GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS
K162541	syngo Application Software	Nov 16, 2016	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC
K161515	eUnity	Nov 15, 2016	Substantially Equivalent	Client Outlook Inc.
K161634	IPS CaseDesigner	Nov 10, 2016	Substantially Equivalent	NOBEL BIOCARE AB
K162513	Arterys Software v2.0	Oct 28, 2016	Substantially Equivalent	ARTERYS INC.
K162145	vRad PACS with Mammography	Oct 25, 2016	Substantially Equivalent	Virtual Radiologic Corporation
K162474	Artemis	Oct 21, 2016	Substantially Equivalent	EIGEN
K162025	IntelliSpace Portal Platform	Oct 18, 2016	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
K162011	MedDream	Oct 14, 2016	Substantially Equivalent	SOFTNETA UAB
K160371	NovaPACS	Oct 14, 2016	Substantially Equivalent	NOVARAD CORPORATION
K161109	iSR'obot MRI-US Fusion	Oct 06, 2016	Substantially Equivalent	BIOBOT SURGICAL PTE LTD
K160666	Dentiq3D	Oct 05, 2016	Substantially Equivalent	3D INDUSTRIAL IMAGING CO.,LTD.
K161828	kneeEOS	Oct 03, 2016	Substantially Equivalent	ONEFIT Medical
K162339	Scenium	Sep 21, 2016	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC
K162112	CAAS MRV	Sep 21, 2016	Substantially Equivalent	Pie Medical Imaging BV
K161625	PixelShine	Sep 19, 2016	Substantially Equivalent	ALGOMEDICA
K162008	JiveX	Sep 16, 2016	Substantially Equivalent	VISUS TECHNOLOGY TRANSFER GMBH
K162141	Restore PACS	Sep 02, 2016	Substantially Equivalent	XIAN WINGSPAN ELECTRONIC TECHNOLOGY CO., LTD.
K153705	PROcedure Rehearsal Studio	Sep 02, 2016	Substantially Equivalent	3DSYSTEMS, SIMBIONIX PRODUCTS
K161130	ResolutionMD	Aug 24, 2016	Substantially Equivalent	CALGARY SCIENTIFIC, INC.
K161518	PACS CORE/ENCORE	Aug 17, 2016	Substantially Equivalent	COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
K152949	WebPAX	Aug 17, 2016	Substantially Equivalent	HEART IMAGING TECHNOLOGIES, LLC
K161955	5D Viewer	Aug 10, 2016	Substantially Equivalent	SAMSUNG Medison Co., Ltd.
K161148	icobrain	Aug 09, 2016	Substantially Equivalent	Icometrix
K161113	QXLink	Aug 05, 2016	Substantially Equivalent	VIEWORKS CO., LTD.
K160284	JointPoint	Aug 03, 2016	Substantially Equivalent	JOINTPOINT, INC.
K160937	Senolris	Aug 01, 2016	Substantially Equivalent	GE Healthcare
K161382	LVivo Software Application	Jul 28, 2016	Substantially Equivalent	DIACARDIO, LTD.
K161118	SIMPLANT Online Case Review and SIMPLANT Editor	Jul 28, 2016	Substantially Equivalent	DENTSPLY SIRONA
K161419	Multi Modality Viewer	Jul 13, 2016	Substantially Equivalent	VITAL IMAGES, INC.
K161685	syngo®.via protoNeo (Version VA10A)	Jul 11, 2016	Substantially Equivalent	SIEMENS HEALTHCARE GMBH
K161479	hipEOS	Jun 28, 2016	Substantially Equivalent	ONEFIT MEDICAL
K160584	Surgical Navigation Advanced Platform (SNAP)	Jun 28, 2016	Substantially Equivalent	SURGICAL THEATER, LLC
K161559	Kuvia3D	Jun 23, 2016	Substantially Equivalent	4QIMAGING, LLC DBA QMETRICS
K161061	IMPAX Volume Viewing 4.0	Jun 22, 2016	Substantially Equivalent	AGFA HEALTHCARE N.V.
K161444	DBSWIN and VistaEasy Imaging Software	Jun 21, 2016	Substantially Equivalent	Duerr Dental AG
K160334	Advanced Medical Imaging Software Suite (KSWVWR)	Jun 21, 2016	Substantially Equivalent	KEOSYS SAS
K153351	Quantib Brain 1	Jun 17, 2016	Substantially Equivalent	QUANTIB BV
K161188	HEPATIQ 1.1	Jun 09, 2016	Substantially Equivalent	HEPATIQ LLC
K161246	Ez3D-i / E3	May 31, 2016	Substantially Equivalent	EWOO SOFT CO., LTD.
K153736	3mensio Workstation	May 27, 2016	Substantially Equivalent	Pie Medical Imaging B.V.
K161117	EzDent-i / E2 / Prora View	May 13, 2016	Substantially Equivalent	EWOO SOFT CO., LTD.
K151913	MIM-Thin Client (mobile)	Apr 25, 2016	Substantially Equivalent	MIM Software Inc.
K160914	sterEOS Workstation	Apr 22, 2016	Substantially Equivalent	EOS IMAGING, INC.
K153653	DICOM Viewer	Apr 13, 2016	Substantially Equivalent	Brainlab AG
K160376	EndoSize	Apr 12, 2016	Substantially Equivalent	Therenva SAS
K160579	Xmaru View V1 and Xmaru PACS, Medical Image Processing Software	Apr 08, 2016	Substantially Equivalent	RAYENCE CO., LTD
K160407	spineEOS	Apr 08, 2016	Substantially Equivalent	ONEFIT MEDICAL
K153284	Synaptive ImageDrive Pro	Mar 29, 2016	Substantially Equivalent	SYNAPTIVE MEDICAL INC.
K152716	EV Insite System	Mar 24, 2016	Substantially Equivalent	PSP Corporation
K160150	Vitrea CT Colon Analysis	Mar 16, 2016	Substantially Equivalent	Vital Images, Inc.
K153355	Xeleris 4.0 Processing and Review Workstation	Mar 16, 2016	Substantially Equivalent	GE HEALTHCARE
K153612	ArthrexVIP Web Portal	Mar 15, 2016	Substantially Equivalent	CUSTOM ORTHOPAEDIC SOLUTIONS, INC.
K160426	syngo.via MI Workflows	Mar 04, 2016	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K153346	syngo Application Software VD11	Mar 04, 2016	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K152602	Olea Sphere V3.0	Mar 03, 2016	Substantially Equivalent	OLEA MEDICAL
K160317	syngo.via MI Workflows	Feb 29, 2016	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K153091	IMPLANT 3D	Feb 25, 2016	Substantially Equivalent	Media Lab S.r.l.
K151737	MedicVOD System	Feb 25, 2016	Substantially Equivalent	Orpheus Medical Ltd.
K152034	FS-PACS	Feb 23, 2016	Substantially Equivalent	EC-WEB CO., LTD.
K160315	I4 (Integrated Intelligent Imaging Informatics) system	Feb 19, 2016	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND BV
K143290	DBSWIN and VistaEasy Imaging Software	Feb 18, 2016	Substantially Equivalent	Durr Dental AG
K153593	CliniscanSM MRI	Feb 17, 2016	Substantially Equivalent	PICOFEMTO LLC
K160001	TraumaCad Mobile Release 2.0	Feb 12, 2016	Substantially Equivalent	Voyant Health Ltd
K153103	CARESTREAM Vue PACS	Feb 12, 2016	Substantially Equivalent	CARESTREAM HEALTH, INC.
K160108	Synapse PACS	Feb 03, 2016	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K153166	Fusion Bx	Jan 25, 2016	Substantially Equivalent	FOCAL HEALTCARE INC.
K152977	DG PACS	Jan 25, 2016	Substantially Equivalent	DICOM GRID, INC.
K152352	Stereo 3D option for Vision Applications	Jan 20, 2016	Substantially Equivalent	GE MEDICAL SYSTEMS, SCS
K153289	HEALTHMYNE	Jan 15, 2016	Substantially Equivalent	HEALTHMYNE, INC
K151075	BR-ABVS Viewer 1.0	Jan 15, 2016	Substantially Equivalent	TAIHAO MEDICAL INC.
K151152	ImplantMax Software	Jan 12, 2016	Substantially Equivalent	SATURN IMAGING INC.
K153427	Volpara Imaging Software	Jan 07, 2016	Substantially Equivalent	Matakina Technology LTD
K152746	Ez3D Plus	Jan 03, 2016	Substantially Equivalent	EWOO SOFT CO., LTD.
K152172	Econsole1	Dec 14, 2015	Substantially Equivalent	DRTECH CORPORATION
K152078	Implant Studio 2015	Dec 04, 2015	Substantially Equivalent	3Shape Medical A/S
K152822	VidiStar HeartView	Nov 25, 2015	Substantially Equivalent	VIDISTAR, LLC
K153022	Philips IntelliSpace Cardiovascular	Nov 18, 2015	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NETHRLANDS BV
K153073	UroNav (Version 2.0)	Nov 16, 2015	Substantially Equivalent	INVIVO CORPORATION
K152661	HICAT Air	Nov 16, 2015	Substantially Equivalent	HICAT GmbH
K151212	Ziostation2	Nov 04, 2015	Substantially Equivalent	QI IMAGING, LLC
K152028	Volpara Imaging Software	Oct 26, 2015	Substantially Equivalent	MATAKINA TECHNOLOGIES LIMITED
K151988	Visible Patient Suite	Oct 15, 2015	Substantially Equivalent	VISIBLE PATIENT, SAS
K151941	DEXIS Webview	Oct 07, 2015	Substantially Equivalent	Imaging Sciences International /Gendex/Dexis
K151501	OrthoVis Web Portal	Oct 02, 2015	Substantially Equivalent	CUSTOM ORTHOPAEDIC SOLUTIONS,INC.
K151774	CARESTREAM Vue Motion	Sep 21, 2015	Substantially Equivalent	CARESTREAM HEALTH, INC.
K143586	FACT Medical Imaging Sysytem	Sep 02, 2015	Substantially Equivalent	Dexin Medical Imaging Technology Co., Ltd.
K151957	BOX DICOM Viewer	Sep 01, 2015	Substantially Equivalent	BOX INC.
K152186	HealthMyne PACS	Aug 20, 2015	Substantially Equivalent	HEALTHMYNE, INC.
K151837	CS 3D Imaging	Aug 19, 2015	Substantially Equivalent	TROPHY
K151371	Corporate Dental Imaging (CDI) Application	Aug 19, 2015	Substantially Equivalent	U.S. ARMY DENTAL COMMAND (DENCOM)
K151859	Synapse Cardiovascular	Aug 12, 2015	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K151850	McKesson Cardiology	Aug 11, 2015	Substantially Equivalent	MCKESSON ISRAEL LTD.
K151353	syngo.MR Neurology, syngo.MR Oncology	Aug 07, 2015	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K151687	QuantorView	Aug 03, 2015	Substantially Equivalent	3DISC AMERICAS
K151568	Arthrex OrthoVis Preoperative Plan	Jul 31, 2015	Substantially Equivalent	Custom Orthopaedic Solutions, Inc.
K151808	3D/5D Viewer	Jul 29, 2015	Substantially Equivalent	SAMSUNG MEDISON CO., LTD
K143368	GenIQ	Jul 29, 2015	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC.
K151854	3MP (X213C3P0E, X213G3P0E) and 2MP (X213C2P0E, X213G2P0E) LCD Display	Jul 28, 2015	Substantially Equivalent	D-VIEW DISPLAY TECHNOLOGY CO., LTD.
K143176	UltraLinq	Jul 17, 2015	Substantially Equivalent	ULTRALINQ HEALTHCARE SOLUTIONS, INC.
K151091	Vitrea Software Toshiba Package, VSTP-001A	Jul 13, 2015	Substantially Equivalent	Toshiba Medical Systems Corporation
K150313	Ablation Confirmation	Jul 09, 2015	Substantially Equivalent	NEUWAVE MEDICAL INC.
K151438	Dentrix Ascend Imaging	Jul 07, 2015	Substantially Equivalent	REALCLOUD IMAGING INC.
K142750	JiveX	Jun 26, 2015	Substantially Equivalent	VISUS TECHNOLOGY TRANSFER GMBH
K151192	syngo.via MI Workflows	Jun 23, 2015	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC
K150415	NilRead	Jun 12, 2015	Substantially Equivalent	Perceptive Software
K150761	Ez3D-i/E3	Jun 05, 2015	Substantially Equivalent	EWOO SOFT CO., LTD
K150976	Collage	Jun 04, 2015	Substantially Equivalent	ANATOMAGE INC.
K151115	MR Core Software	Jun 03, 2015	Substantially Equivalent	Vital Images, Inc
K143397	ICIS View	Jun 01, 2015	Substantially Equivalent	Agfa HealthCare N.V.
K150707	IntelePACS	May 27, 2015	Substantially Equivalent	INTELERAD MEDICAL SYSTEMS INCORPORATED
K150420	Centricity Universal Viewer	May 26, 2015	Substantially Equivalent	GE HEALTHCARE
K150069	Fine Structure Analysis(fineSA)	May 22, 2015	Substantially Equivalent	Acuitas Medical Ltd.
K142648	SPINEDESIGN Spine Surgery Planning (Software Application)	May 22, 2015	Substantially Equivalent	MEDTRONIC SOFAMOR DANEK USA, INC.
K142196	Visage Ease Pro	Apr 28, 2015	Substantially Equivalent	VISAGE IMAGING GMBH
K150843	syngo®.via (version VB10A)	Apr 24, 2015	Substantially Equivalent	Siemens AG
K142779	SCANIP; SCANIP: MEDICAL EDITION; SCANIP: MED	Apr 17, 2015	Substantially Equivalent	SIMPLEWARE LTD.
K142647	mint Lesion	Apr 13, 2015	Substantially Equivalent	MINT MEDICAL GMBH
K150738	VitreaView	Apr 06, 2015	Substantially Equivalent	Vital Images, Inc
K150747	EzDent-i /E2/Prora View	Apr 02, 2015	Substantially Equivalent	LK Consulting Group USA, Inc.
K150192	Scenium	Mar 29, 2015	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC
K143361	Mammo Workstation	Mar 26, 2015	Substantially Equivalent	GE HEALTHCARE
K150193	Customer Remote Console (CRC)	Mar 24, 2015	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K142337	Blackford Analysis Registration Product Family	Mar 19, 2015	Substantially Equivalent	BLACKFORD ANALYSIS LTD
K143318	DR Systems Zero Download 3D Viewer (Z3D)	Mar 10, 2015	Substantially Equivalent	DR Systems, Inc
K141536	VIEWING CLIENT MOBILE	Mar 06, 2015	Substantially Equivalent	AXON MEDICAL TECHNOLOGIES CORP.
K150258	Vitrea, Version 7.0 Medical Image Processing Software	Mar 05, 2015	Substantially Equivalent	Vital Images, Inc
K142923	TraumaCad Mobile Release 1.0	Mar 05, 2015	Substantially Equivalent	Voyant Health Ltd
K150085	GE EchoPAC	Mar 02, 2015	Substantially Equivalent	GE VINGMED ULTRASOUND AS
K143319	Syngo X-workplace SW VD10	Feb 24, 2015	Substantially Equivalent	Siemens Medical Solutions, Inc
K150122	TOMTEC-ARENA TTA2	Feb 13, 2015	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K143044	CAAS A-Valve	Feb 06, 2015	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K140828	NEUROREADER MEDICAL IMAGE PROCESSING SOFTWARE	Feb 04, 2015	Substantially Equivalent	BRAINREADER APS
K142107	ECHO TRUE 3D VIEWER	Jan 21, 2015	Substantially Equivalent	ECHO PIXEL INC.
K141561	VM PACS WITH VM MEDICAL WORKSTATION	Jan 16, 2015	Substantially Equivalent	VISUAL MEDICA
K142850	McKesson Radiology Mammography Plus	Jan 06, 2015	Substantially Equivalent	MCKESSON MEDICAL IMAGING COMPANY
K142316	IMPAX Agility	Jan 06, 2015	Substantially Equivalent	AGFA HEALTHCARE N.V.
K140587	MR-CT VVA	Jan 06, 2015	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K142514	UniWeb 8.0	Dec 18, 2014	Substantially Equivalent	EBM Technologies Incorporated
K142891	HEPATIQ	Dec 17, 2014	Substantially Equivalent	HEPATIQ LLC
K142944	ArthroPlan Digital Templating Software	Dec 16, 2014	Substantially Equivalent	Arthromeda, Inc
K142919	EXA	Dec 16, 2014	Substantially Equivalent	Viztek LLC
K140860	ImmersiveTouch3 and MicrovisTouch	Dec 16, 2014	Substantially Equivalent	IMMERSIVE TOUCH
K140797	IPACS MEDICAL IMAGE MANAGEMENT SYSTEM	Dec 12, 2014	Substantially Equivalent	VISBION LIMITED
K143254	eSie Apps Suite	Dec 10, 2014	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K142671	ONEFIT HIP PLANNER	Dec 05, 2014	Substantially Equivalent	ONEFIT MEDICAL
K143079	Endovascular Stent Planning Software	Dec 04, 2014	Substantially Equivalent	VITAL IMAGES, INC.
K142521	Synapse 3D Liver and Kidney Analysis	Dec 01, 2014	Substantially Equivalent	FUJIFILM MEIDCAL SYSTEMS U.S.A.,INC.
K141881	RAPIDRESULTS	Oct 31, 2014	Substantially Equivalent	RAMSOFT, INC.
K141745	IQQA-BODYIMAGING SOFTWARE	Oct 31, 2014	Substantially Equivalent	EDDA TECHNOLOGY
K141570	IMPLANT STUDIO	Oct 31, 2014	Substantially Equivalent	3SHAPE MEDICAL A/S
K132853	NOVAPACS	Oct 30, 2014	Substantially Equivalent	NOVARAD CORP.
K142037	QUANTRA	Oct 10, 2014	Substantially Equivalent	HOLOGIC, INC.
K141669	SURGIMAP	Sep 19, 2014	Substantially Equivalent	NEMARIS INC
K141607	DENTAL IMAGING SOFTWARE	Sep 18, 2014	Substantially Equivalent	TROPHY
K140399	EBM IDO VIEWER	Sep 18, 2014	Substantially Equivalent	EBM TECHNOLOGIES USA, LLC
K142048	EMPRINT PROCEDURE PLANNING APPLICATION	Sep 17, 2014	Substantially Equivalent	Covidien LLC
K141137	STEREOS WORKSTATION	Sep 15, 2014	Substantially Equivalent	EOS IMAGING
K141514	SYNAPSE 3D TENSOR ANALYSIS	Sep 03, 2014	Substantially Equivalent	FUJIFILM MEIDCAL SYSTEMS U.S.A..,INC.
K141364	CLIMB MAMMOGRAPHY VIEWER SOFTWARE	Aug 29, 2014	Substantially Equivalent	CLIMB MEDICAL SYSTEMS, INC.
K141451	VixWin Platinum	Aug 26, 2014	Substantially Equivalent	IMAGING SCIENCES INTERNATIONAL (DBA GENDEX LLC)
K141480	CVI42	Aug 22, 2014	Substantially Equivalent	CIRCLE CARDIOVASCULAR IMAGING INC
K131348	ORTOMED	Aug 05, 2014	Substantially Equivalent	INFOMED SERVICIOS INFORMATICOS S.L.
K141302	VITREA CT MULTI-CHAMBER CARDIAC FUNCTIONAL ANALYSIS (CFA)	Aug 01, 2014	Substantially Equivalent	VITAL IMAGES, INC.
K141061	REMOTEYE VIEWER	Aug 01, 2014	Substantially Equivalent	NEOLOGICA S.R.L.
K141475	ENDOSIZE	Jul 31, 2014	Substantially Equivalent	THERENVA SAS
K140897	SYNGO.MR NEUROLOGY, SYNGO.MMR GENERAL	Jul 18, 2014	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K141554	ESIE APPS SUITE	Jul 11, 2014	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K140869	DCAS I	Jul 03, 2014	Substantially Equivalent	GP&P CO., LTD.
K141556	AVREO INTERWORKS SYSTEM	Jul 02, 2014	Substantially Equivalent	AVREO, INC.
K140909	MCKESSON RADIOLOGY	Jul 02, 2014	Substantially Equivalent	MCKESSON MEDICAL IMAGING COMPANY
K140819	SURGICAL NAVIGATION ADVANCED PLATFORM	Jun 27, 2014	Substantially Equivalent	SURGICAL THEATER, LLC
K141329	RADSPA	Jun 20, 2014	Substantially Equivalent	TELERAD TECH PRIVATE LIMITED
K141199	QUENTRY DOSE REVIEW	Jun 20, 2014	Substantially Equivalent	BRAINLAB AG
K140713	PLANMECA ROMEXIS	Jun 16, 2014	Substantially Equivalent	PLANMECA OY
K140960	PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM	Jun 13, 2014	Substantially Equivalent	HOLOGIC, INC.
K133098	SENYINT PACS	Jun 13, 2014	Substantially Equivalent	DALIAN SENYINT DIGITAL MEDICAL SYSTEM CO., LTD.
K140434	MEDICAD CLASSIC	Jun 05, 2014	Substantially Equivalent	HECTEC GMBH
K140337	BRIGHTMATTER PLANNING SOFTWARE	Jun 02, 2014	Substantially Equivalent	SYNAPTIVE MEDICAL INC.
K140139	CLEARVIEWHD	May 28, 2014	Substantially Equivalent	CLEARVIEW DIAGNOSTICS INC.
K132684	MEDWS SOFTWARE (VARIANTS MEDVIEW, MEDDIAG, MEDMAMMO)	May 23, 2014	Substantially Equivalent	MEDECOM SARL
K140395	VITREA IMAGE DENOISING SOFTWARE	May 13, 2014	Substantially Equivalent	VITAL IMAGES, INC.
K140445	DEXIS SOFTWARE: DEXIS IMAGING SUITE, DEXIS MAC	Apr 23, 2014	Substantially Equivalent	IMAGING SCIENCES INTERNATIONAL, LLC
K140808	Q-STATION	Apr 17, 2014	Substantially Equivalent	PHILIPS ULTRASOUND, INC.
K133521	AZE PHOENIX SOFTWARE	Apr 11, 2014	Substantially Equivalent	AZE, LTD.
K133910	NORDICBRAINEX	Apr 04, 2014	Substantially Equivalent	NORDICNEUROLAB
K140271	TABLET VIEWER SOFTWARE FOR IMAGE SUITE	Apr 01, 2014	Substantially Equivalent	CARESTREAM HEALTH, INC.
K133984	CORONIS 5MP	Mar 28, 2014	Substantially Equivalent	BARCO NV
K133508	RESOLUTIONMD MOBILE	Mar 26, 2014	Substantially Equivalent	CALGARY SCIENTIFIC, INC.
K133663	NIO COLOR 2MP	Mar 25, 2014	Substantially Equivalent	BARCO N.V.
K133401	SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL	Mar 11, 2014	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K140093	TABLE	Mar 07, 2014	Substantially Equivalent	ANATOMAGE INC.
K133135	IMPAX VOLUME VIEWING 3.0	Mar 07, 2014	Substantially Equivalent	AGFA HEALTHCARE N.V.
K133966	MODEL-BASED RSA SOFTWARE	Mar 06, 2014	Substantially Equivalent	HALIFAX BIOMEDICAL, INC.
K133022	ZEDVIEW	Mar 06, 2014	Substantially Equivalent	LEXI CO., LTD.
K133937	HEARTSCAN SOFTWARE	Mar 03, 2014	Substantially Equivalent	MORPHEUS IMAGING, INC
K133654	SCENIUM	Feb 28, 2014	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K133609	THE DOME S6C	Feb 28, 2014	Substantially Equivalent	NDS SURGICAL IMAGING
K132763	ADVANCED VIEWER	Feb 28, 2014	Substantially Equivalent	BRAINLAB, AG
K140033	TARGET3D FUSION	Feb 27, 2014	Substantially Equivalent	CONVERGENT LIFE SCIENCES, INC.
K133385	LUNGPOINT ATV PLANNING AND NAVIGATION SOFTWARE	Feb 26, 2014	Substantially Equivalent	BRONCUS MEDICAL INC
K133644	SYNGO.VIA MI WORKFLOWS	Feb 25, 2014	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K133320	SICAT FUNCTION	Feb 25, 2014	Substantially Equivalent	SICAT GMBH & CO. KG
K140214	30.0 INCH COLOR LCD MONITOR CCL650I2 (CL30650, MD302C6)	Feb 19, 2014	Substantially Equivalent	JVC KENWOOD CORPORATION
K140108	3MP COLOR LCD DISPLAY	Feb 14, 2014	Substantially Equivalent	SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD
K140103	3MP GRAYSCAKE LCD DISPLAY	Feb 14, 2014	Substantially Equivalent	SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD
K133708	MD302C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR	Feb 14, 2014	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K132824	CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION	Feb 06, 2014	Substantially Equivalent	CARESTREAM HEALTH,INC.
K134002	6MP COLOR LCD MONITOR, RADIFORCE RX650	Jan 31, 2014	Substantially Equivalent	EIZO CORPORATION
K133730	CO PILOT/REGIUS UNITEA	Jan 31, 2014	Substantially Equivalent	KONICA MINOLTA INC.
K132770	DOME S10	Jan 30, 2014	Substantially Equivalent	NDS SURGICAL IMAGING
K133030	DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE)	Jan 22, 2014	Substantially Equivalent	INVIVO CORPORATION
K132499	ICRCO CLARITY VIEWER	Jan 21, 2014	Substantially Equivalent	ICRCO INC.
K133875	THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.2, THE MOTION NORMALIZER PATIENT HANDLING AND DATA	Jan 17, 2014	Substantially Equivalent	ORTHO KINEMATICS, INC.
K133686	21.3 INCH (54 CM) INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS35i2 (ML21035)	Jan 06, 2014	Substantially Equivalent	JVC KENWOOD CORPORATION
K130998	SYNGO.VIA WEB VIEWER	Jan 03, 2014	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K132095	OLEA SPHERE	Dec 26, 2013	Substantially Equivalent	OLEA MEDICAL
K131447	INTUITION - TDA, TVA, PARAMETRIC MAPPING	Dec 24, 2013	Substantially Equivalent	TERARECON, INC.
K133367	ORTHOVIS PREOPERATIVE PLAN	Dec 20, 2013	Substantially Equivalent	CUSTOM ORTHOPAEDIC SOLUTIONS
K132342	XVWEB	Dec 20, 2013	Substantially Equivalent	APTERYX, INC.
K133511	21.3 INCH(54 CM) MONOCHROME LCD MONITOR MS25I2(ML21025)	Dec 19, 2013	Substantially Equivalent	JVC KENWOOD CORPORATION
K132963	FUSIONSYNC, CHIMAERA FUSIONSYNC	Dec 16, 2013	Substantially Equivalent	CHIMAERA GMBH
K132773	SIDEXIS 4	Dec 11, 2013	Substantially Equivalent	SIRONA DENTAL SYSTEMS GMBH
K132532	SYNGO.PLAZA VB10A	Dec 09, 2013	Substantially Equivalent	SIEMENS AG HEALTHCARE
K133185	21.3 INCH (54 CM) COLOR LCD MONITOR CCL358I2 (CL21358)	Dec 03, 2013	Substantially Equivalent	JVC KENWOOD CORPORATION
K133181	21.3 INCH (54 CM) COLOR LCD MONITOR CCL258I2 (CL21258)	Dec 03, 2013	Substantially Equivalent	JVC KENWOOD CORPORATION
K132742	M-VU BREAST DENSITY	Dec 03, 2013	Substantially Equivalent	VUCOMP, INC.
K131390	JUSHA-M52C MEDICAL DISPLAY	Nov 27, 2013	Substantially Equivalent	NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
K133357	CHARRUAPACS SYSTEM	Nov 25, 2013	Substantially Equivalent	CHARRUASOFT SA
K132544	TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA	Nov 25, 2013	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K132799	CLARISO PACS	Nov 07, 2013	Substantially Equivalent	CLARISO, INC.
K132586	PAXERAPACS	Oct 31, 2013	Substantially Equivalent	PAXERAMED
K132316	MULTIVIEW	Oct 30, 2013	Substantially Equivalent	HOLOGIC, INC.
K132188	MAMMOGRAPHY VIEWER SMV658	Oct 25, 2013	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K132636	DYONICS PLAN HIP IMPINGEMENT PLANNING SYSTEM	Oct 17, 2013	Substantially Equivalent	SMITH & NEPHEW, INC.
K121447	ISCHEMA VIEW RAPID	Oct 04, 2013	Substantially Equivalent	ISCHEMA VIEW, INC.
K122536	AMCAD-UT DETECTION MODEL 2.0	Oct 03, 2013	Substantially Equivalent	LIN & ASSOCIATES, LLC.
K131873	NDOHD HIGH DEFINITION IMAGING SYSTEM (NDOHD)	Sep 25, 2013	Substantially Equivalent	METHODSENSE, INC.
K131685	GE ECHOPAC	Sep 24, 2013	Substantially Equivalent	GE VINGMED ULTRASOUND AS
K131977	CENTRICITY UNIVERSAL VIEWER ZERO FOOTPRINT CLIENT	Sep 17, 2013	Substantially Equivalent	GE HEALTHCARE
K132302	QXLINK	Sep 12, 2013	Substantially Equivalent	VIEWORKS CO., LTD.
K131389	JUSHA-C31 MEDICAL DISPLAY	Sep 06, 2013	Substantially Equivalent	NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
K123944	KOSTEC MEDICAL GRADE LDC MONITORS	Sep 05, 2013	Substantially Equivalent	KOSTEC CO., LTD
K132610	5MP GRAYSCALE LCD DISPLAY	Sep 04, 2013	Substantially Equivalent	SHENZHEN BEACON DISPLAY TECHNOLOGY CO., LTD
K132587	MD242C2 24 DIAGNOSTIC IMAGING LCD MONITOR	Aug 29, 2013	Substantially Equivalent	NED DISPLAY SOLUTIONS LTD.
K131616	EZ3D-I, E3	Aug 29, 2013	Substantially Equivalent	EWOO SOFT CO., LTD
K131594	EZDENTI-I; E2; PRORA VIEW	Aug 29, 2013	Substantially Equivalent	EWOO SOFT CO., LTD
K130374	OMNI-VUE 2 SYSTEM	Aug 29, 2013	Substantially Equivalent	GENESIS DIGITAL IMAGING, INC.
K130242	MAVEN PRO	Aug 29, 2013	Substantially Equivalent	NSEQUENCE
K131391	JUSHA-M32 MEDICAL DISPLAY	Aug 21, 2013	Substantially Equivalent	NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD
K131158	CORVIEW	Aug 21, 2013	Substantially Equivalent	MARREK, INC
K130749	SYNGO.MR GENERAL; SYNGO.MR CARDIOLOGY; SYNGO.MR VASCULAR	Aug 20, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K131570	ORTHOVISION	Aug 15, 2013	Substantially Equivalent	EWOO SOFT CO., LTD
K130779	LVIVO EF SYSTEM	Aug 15, 2013	Substantially Equivalent	DIACARDIO, LTD
K132165	QLAB QUANTIFICATION SOFTWARE	Aug 09, 2013	Substantially Equivalent	PHILIPS ULTRASOUND, INC.
K130743	THE KINEGRAPH VMA (VERTEBRAL MOTION ANALYZER) SOFTWARE VERSION 2.0; THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLL	Aug 06, 2013	Substantially Equivalent	ORTHO KINEMATICS, INC.
K131448	3D PROSTATE SUITE 3DTRUS PROSTATE MAPPING, MRI/3DTRUS FUSION OPTION, SECOND LOOK 3DTRUS FUSION OPTION	Jul 26, 2013	Substantially Equivalent	KOELIS
K131498	IQQA-LIVER MULTIMODALITY SOFTWARE	Jul 25, 2013	Substantially Equivalent	EDDA TECHNOLOGY, INC.
K132062	ESIE APPS SUITE	Jul 23, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K131822	ULTRAEXTEND USWS-900A V2.1 AND V3.1	Jul 23, 2013	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K131137	21.3 INCH MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS55I2 (ML21055, MD211G5)	Jul 18, 2013	Substantially Equivalent	JVC KENWOOD CORPORATION
K131424	MIPLATFORM MEDICAL IMAGING SUITE	Jul 12, 2013	Substantially Equivalent	HINACOM SOFTWARE AND TECHNOLOGY, LTD.
K131090	2MP COLOR LCD MONITOR, RADIFORCE MX215	Jul 03, 2013	Substantially Equivalent	EIZO CORPORATION
K130724	CODIAGNOSTIX IMPLANT PLANNING SOFTWARE	Jun 28, 2013	Substantially Equivalent	STRAUMANN USA
K130542	SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS	Jun 14, 2013	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K131392	ETIAM PACS COMPONENTS	May 29, 2013	Substantially Equivalent	ETIAM S.A.S.U.
K131295	NIO COLOR 3MP LED	May 29, 2013	Substantially Equivalent	BARCO NV
K130278	MR PERMEABILITY	May 29, 2013	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K131246	CORONIS 3MP	May 24, 2013	Substantially Equivalent	BARCO N.V.
K131299	ANYTHINK PACS WORKSTATION	May 22, 2013	Substantially Equivalent	BEIJING CREALIFE TECHNOLOGY CO., LTD.
K123306	NORDIC TUMOREX	May 20, 2013	Substantially Equivalent	NORDICNEUROLAB
K124051	THE VAULT SYSTEM	May 17, 2013	Substantially Equivalent	SOMERSAULT ORTHOPEDICS, INC.
K131118	4D VIEW	May 16, 2013	Substantially Equivalent	GE HEALTHCARE
K123082	MOBILECT VIEWER	May 16, 2013	Substantially Equivalent	NEPHOSITY, INC.
K130159	QLAB QUANTIFICATION SOFTWARE HEART MODEL	May 13, 2013	Substantially Equivalent	PHILIPS HEALTHCARE
K130624	CONI	May 07, 2013	Substantially Equivalent	GLOBALMED
K130772	MD211C2 21.3 DIAGNOSTIC IMAGING LCD MONITOR	Apr 18, 2013	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K130770	MD211C3 21.3 DIAGNOSTIC IMAGING LCD MONITOR	Apr 18, 2013	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K130929	ZMED VP4000	Apr 12, 2013	Substantially Equivalent	ZMED, INC.
K130884	XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION	Apr 12, 2013	Substantially Equivalent	GE MEDICAL SYSTEMS F.I. HAIFA
K130383	SYNAPSE 3D CARDIAC TOOLS	Apr 09, 2013	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K130069	INNOVA EPVISION 2.0, INNOVA EPVISION 2.0	Apr 05, 2013	Substantially Equivalent	GE HEALTHCARE
K121916	INTUITION	Apr 02, 2013	Substantially Equivalent	TERARECON, INC.
K130336	5MP MONOCHROME LCD MONITOR, RADIFORCE GX540	Mar 28, 2013	Substantially Equivalent	EIZO NANAO CORPORATION
K123976	NOBELCLINICIAN	Mar 26, 2013	Substantially Equivalent	NOBEL BIOCARE AB
K130393	MIRADA RTX	Mar 20, 2013	Substantially Equivalent	MIRADA MEDICAL LTD.
K130228	SUITEHEART	Mar 20, 2013	Substantially Equivalent	NEOSOFT, LLC
K123186	RESOLUTIONMD MOBILE 3.1 MODEL RMD-MOB-31	Mar 14, 2013	Substantially Equivalent	CALGARY SCIENTIFIC, INC.
K130395	STEREOS WORKSTATION	Mar 11, 2013	Substantially Equivalent	EOS IMAGING INC.
K123426	MEDICVOD, MEDICAST, MEDISHOW, MEDISEARCH, CENTRAL STORAGE SYSTEM - CSS	Mar 01, 2013	Substantially Equivalent	ORPHEUS MEDICAL, LTD.
K122578	VITREA CT TRANSCATHETER AORTIC VALVE REPLACMENT (TAVR) PLANNING	Feb 25, 2013	Substantially Equivalent	VITAL IMAGES, INC.
K123650	ARIX RAD ACQUISITION CONSOLE	Feb 20, 2013	Substantially Equivalent	COMPANIA MEXICANA DE RADIOLOGIA CGR, S.A. DE C.V.
K123575	MAMMOWORKSTATION	Feb 19, 2013	Substantially Equivalent	IMAGE DIAGNOST INTERNATIONAL GMBH
K120851	COMMUNIFY PACS VIEWER	Feb 19, 2013	Substantially Equivalent	COMMUNIFY HEALTH, LLC
K130103	CORONIS FUSION 6MP	Feb 08, 2013	Substantially Equivalent	BARCO N.V.
K130070	4MP COLOR LCD MONITOR, RADIFORCE RX440	Feb 08, 2013	Substantially Equivalent	EIZO NANAO CORPORATION
K123023	SURGERY REHEARSAL PLATFORM	Feb 08, 2013	Substantially Equivalent	SURGICAL THEATER, LLC
K123970	CAAS INTRAVASCULAR	Feb 06, 2013	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K123519	INVIVO DENTAL	Feb 01, 2013	Substantially Equivalent	ANATOMAGE, INC
K123420	SYNGO, BREAST CARE	Feb 01, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K124048	IMAGEQUBE	Jan 29, 2013	Substantially Equivalent	INTUITIVE IMAGING INFORMATICS, LLC
K123901	TRACTUS TISSUEMAPPER REVIEWER APPLICATION	Jan 29, 2013	Substantially Equivalent	TRACTUS CORPORATION
K123894	GE ECHOPAC	Jan 29, 2013	Substantially Equivalent	GE VINGMED ULTRASOUND AS
K123269	PROCEDURE REHEARSAL STUDIO	Jan 29, 2013	Substantially Equivalent	SIMBIONIX LTD.
K123577	SYNGO.VIA MI WORKFLOWS	Jan 22, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K123566	SYNAPSE 3D COLON ANALYSIS	Jan 22, 2013	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K123920	SYNGO.VIA	Jan 18, 2013	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K121762	CARDIAC VX	Jan 18, 2013	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K123922	SYNGO DYNAMICS	Jan 16, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K123302	IB CLINIC	Jan 11, 2013	Substantially Equivalent	IMAGING BIOMETRICS, LLC
K121296	INTERVENTIONAL WORKSPOT	Jan 02, 2013	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K123526	CLEARREAD +CONFIRM	Dec 27, 2012	Substantially Equivalent	RIVERAIN TECHNOLOGIES
K123530	MAMMOGRAPHY PRIOR ENHANCEMENT (MPE)	Dec 20, 2012	Substantially Equivalent	HOLOGIC, INC.
K123528	SCENIUM	Dec 20, 2012	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K120995	ERAD PACS/ERAD RIS/PACS/ERAD EPVLITE VIEWER SOFTWARE PRODUCT	Dec 03, 2012	Substantially Equivalent	ERAD, INC.
K122429	VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL	Nov 28, 2012	Substantially Equivalent	OBJECT RESEARCH SYSTEMS (ORS) INC.
K123375	SYNGO.VIA	Nov 20, 2012	Substantially Equivalent	SIEMENS AG
K123174	CENTRICITY PACS-IW WITH UNIVERSAL VIEWER	Nov 16, 2012	Substantially Equivalent	GE HEALTHCARE
K113344	STEREOS WORKSTATION	Nov 16, 2012	Substantially Equivalent	EOS IMAGING
K121213	VITREAADVANCED	Nov 02, 2012	Substantially Equivalent	VITAL IMAGES, INC.
K121200	FLIGHTPLAN FOR LIVER	Nov 02, 2012	Substantially Equivalent	GE HEALTHCARE
K121781	ECHONAVIGATOR RELEASE 1	Oct 26, 2012	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K122289	IMAGE-COM 5.0	Oct 24, 2012	Substantially Equivalent	TOM TEC IMAGING SYSTEMS GMBH
K122523	CARESTREAM VUE PACS	Oct 23, 2012	Substantially Equivalent	CARESTREAM HEALTH, INC.
K121076	ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE	Oct 09, 2012	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K122843	MD211G3 21.3 DIAGNOSTIC IMAGING LCD MONITOR	Oct 05, 2012	Substantially Equivalent	PRODIGY TECHNOLOGY CONSULTANT CO., LTD.
K122022	ATHEROEDGE	Sep 26, 2012	Substantially Equivalent	ATHEROPOINT LLC
K111142	ECHOSOFT(TM)	Sep 21, 2012	Substantially Equivalent	ECHOMETRIX LLC
K120288	ORTHOCAD SOFTWARE OPTION	Sep 19, 2012	Substantially Equivalent	ESAOTE, S.P.A.
K122427	CS ORTHODONTIC IMAGING SOFTWARE CS OMS IMAGING SOFTWARE	Sep 12, 2012	Substantially Equivalent	CARESTREAM DENTAL LLC
K122260	AYCAN MOBILE	Sep 12, 2012	Substantially Equivalent	AYCAN DIGITALSYSTEME GMBH
K122164	MR VESSELLQ XPRESS	Sep 07, 2012	Substantially Equivalent	GE MEDICAL SYSTEMS SCS
K122136	VITREAVIEW	Sep 07, 2012	Substantially Equivalent	VITAL IMAGES, INC.
K122329	BIOJET	Aug 16, 2012	Substantially Equivalent	JET SOFT SRL
K122205	EXINI	Aug 15, 2012	Substantially Equivalent	EXINI DIAGNOSTICS AB
K120451	8MP COLOR LCD MONITOR, REDIFORCE RX840	Aug 03, 2012	Substantially Equivalent	EIZO NANAO CORPORATION
K120734	MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE	Aug 02, 2012	Substantially Equivalent	MICROSOFT CORP.
K121292	DYNAPBV BODY SOFTWARE	Jul 30, 2012	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K121075	NERVEVISION SOFTWARE SYSTEMS	Jul 26, 2012	Substantially Equivalent	3D IMAGING PARTNERS INC.
K121788	NIO 5MP	Jul 23, 2012	Substantially Equivalent	BARCO NV
K121517	VERSAVUE ENTERPRISE SUITE	Jul 20, 2012	Substantially Equivalent	ICAD, INC.
K113562	3MP COLOR LCD MONITOR, RADIFORCE RX340	Jul 16, 2012	Substantially Equivalent	EIZO NANAO CORPORATION
K113620	MYRIAN 1.11	Jul 12, 2012	Substantially Equivalent	INTRASENSE
K121449	DIRECTPATH	Jul 10, 2012	Substantially Equivalent	CYBERNET SYSTEMS CO., LTD.
K120305	THINKINGNET, THINKINGPACS/RIS - PROPRIETARY NAME FRO THINKINGNET, THINKINGARCHIVE (OR NUPAX) - THE MANAGEMENT AND ARCHIV	Jul 09, 2012	Substantially Equivalent	THINKING SYSTEMS CORP.
K120733	SIMPLANT GO	Jul 05, 2012	Substantially Equivalent	MATERIALISE DENTAL NV
K120636	SYNAPSE 3D CARDIAC TOOLS	Jul 05, 2012	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K120514	CARDIOPACS	Jul 05, 2012	Substantially Equivalent	LUMEDX
K121459	SYNGO.MR NEUROLOGY	Jun 22, 2012	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K120472	QUANTRA	Jun 22, 2012	Substantially Equivalent	HOLOGIC, INC.
K113456	READY VIEW	Jun 15, 2012	Substantially Equivalent	GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
K120648	SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS	Jun 14, 2012	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K121074	SCENIUM 2.0	Jun 08, 2012	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K121387	CENTRICITY PACS-IW	Jun 05, 2012	Substantially Equivalent	GE HEALTHCARE INTEGRATED IT SOLUTIONS
K120679	SYNAPSE 3D NODULE ANALYSIS	Jun 01, 2012	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K121466	GUIDEMIA	May 31, 2012	Substantially Equivalent	GUIDEMIA TECHNOLOGIES, LLC
K121023	SPECTRUM V.0	May 31, 2012	Substantially Equivalent	INTRINSIC MEDICAL IMAGING
K113739	SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM	May 30, 2012	Substantially Equivalent	MATERIALISE DENTAL NV
K121223	QLAB WITH FHN AND VPQ PLUG-IN	May 15, 2012	Substantially Equivalent	PHILIPS ULTRASOUND, INC.
K120637	SYNAPSE 3D BRAIN PERFUSION	May 08, 2012	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K113599	SURGICASE CONNECT	Apr 27, 2012	Substantially Equivalent	MATERIALISE N.V.
K120207	VISIA	Apr 23, 2012	Substantially Equivalent	MEVIS MEDICAL SOLUTIONS AG
K113240	3.7 MP COLOR LCD MONITOR, RADIFORCE MX270W	Apr 20, 2012	Substantially Equivalent	EIZO NANAO CORPORATION
K120718	INSTAPACS/INSTARISPACS	Apr 19, 2012	Substantially Equivalent	MEDDIFF TECHNOLOGIES PVT. LTD
K120407	2MP MONOCHROME LCD MONITOR, RADIFORCE GX240	Apr 19, 2012	Substantially Equivalent	EIZO NANAO CORPORATION
K120196	OLEA SPHERE	Apr 19, 2012	Substantially Equivalent	OLEA MEDICAL
K120076	RESOLUTIONMD WEB	Apr 19, 2012	Substantially Equivalent	CALGARY SCIENTIFIC, INC.
K120367	3MENSIO WORKSTATION	Apr 17, 2012	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K120315	SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION	Apr 13, 2012	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K120161	ALPHAPOINT IMAGING SOFTWARE	Apr 13, 2012	Substantially Equivalent	RADLOGICS, INC.
K120135	2D CARDIAC PERFORMANCE ANALYSIS MR 1.0	Apr 13, 2012	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K120709	THE DOME GX4MP COLOR NONITOR	Apr 06, 2012	Substantially Equivalent	NDS SURGICAL IMAGING
K120361	SYNAPSE 3D BASE TOOLS	Apr 06, 2012	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS USA, INC.
K120187	MULTI-MODALITY IMAGE FUSION	Apr 06, 2012	Substantially Equivalent	IGT LLC DBA EIGEN
K120221	GE ECHOPAC	Mar 30, 2012	Substantially Equivalent	GE HEALTHCARE
K120484	VISIA ONCOLOGY	Mar 27, 2012	Substantially Equivalent	MEVIS MEDICAL SOLUTIONS AG
K120115	ORTHOSIZE	Mar 14, 2012	Substantially Equivalent	ORTHOSIZE LLC
K120525	QLAB QUANTIFICATION SOFTWARE	Mar 09, 2012	Substantially Equivalent	PHILIPS HEALTHCARE GROUP
K113082	SONOVISION	Mar 08, 2012	Substantially Equivalent	PERIDOT TECHNOLOGIES NY INC
K113784	3MP MONOCHROME LCD MONITOR, RADIFORCE GX340	Mar 02, 2012	Substantially Equivalent	EIZO NANAO CORPORATION
K113844	RADIFORCE RX240	Feb 27, 2012	Substantially Equivalent	EIZO NANAO CORPORATION
K112807	X-RAY VVA	Feb 27, 2012	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K112679	SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM	Feb 22, 2012	Substantially Equivalent	MATERIALISE DENTAL NV
K113701	VISIA NEURO	Feb 16, 2012	Substantially Equivalent	MEVIS MEDICAL SOLUTIONS AG
K113442	3DI	Feb 16, 2012	Substantially Equivalent	SHINA SYSTEMS LTD.
K113419	CS IMAGING	Feb 16, 2012	Substantially Equivalent	TROPHY
K111758	CADENS (TM) COLON	Feb 14, 2012	Substantially Equivalent	DOG MICROSYSTEMS, INC.
K113076	CAAS A-VALVE	Jan 30, 2012	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K112720	MCKESSON HORIZON CARDIOLOGY	Jan 30, 2012	Substantially Equivalent	MCKESSON ISRAEL LTD.
K111385	DELL ULTRASHARP U3011 W/QUBYX PERFECTLUM BUNDLE	Jan 30, 2012	Substantially Equivalent	QUBYX LIMITED
K112251	SWISSMEDA DENTAL PLANNING SYSTEM	Jan 25, 2012	Substantially Equivalent	SWISSMEDA AG
K112008	TOUCHPACS SUITE	Jan 06, 2012	Substantially Equivalent	TOUCH MEDICAL SOLUTIONS INC.
K111861	SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE	Jan 06, 2012	Substantially Equivalent	SIEMENS MEDICAL SYSTEMS USA
K111776	DELTAVIEW MODEL 2.1	Dec 28, 2011	Substantially Equivalent	RIVERAIN MEDICAL GROUP,LLC
K112387	PROCEDURE REHEARSAL STUDIO(TM)	Dec 27, 2011	Substantially Equivalent	SIMBIONIX LTD.
K113443	21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)	Dec 23, 2011	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD.
K113244	SYNAPSE MPR FUSION	Dec 22, 2011	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K112109	THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE	Dec 22, 2011	Substantially Equivalent	ORTHO KINEMATICS, INC.
K113136	21.3INCH (54CM)COLOR LCD MONITOR CCL256I2(CL21256)	Dec 20, 2011	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K103554	METRON-CP/MD	Dec 20, 2011	Substantially Equivalent	EPONATECH LLC
K113226	8MP COLOR LCD MONITOR,RADIFORCE RX840	Dec 17, 2011	Substantially Equivalent	EIZO NANAO CORPORATION
K113543	ONDEMAND3D	Dec 16, 2011	Substantially Equivalent	CYBERMED, INC.
K113541	CLEARSTART SVM SYSTEM	Dec 16, 2011	Substantially Equivalent	INTIO INC.
K112480	VIEW 1 IMAGING	Dec 13, 2011	Substantially Equivalent	KARL STORZ ENDOSCOPY AMERICA, INC.
K113404	DENTAL 3D PLANNING SOFTWARE	Dec 06, 2011	Substantially Equivalent	SYMBYO DENTAL, LLC
K112930	MOBILE MIM	Dec 02, 2011	Substantially Equivalent	MIM SOFTWARE INC.
K112570	CENTRICITY CARDIO IMAGING	Nov 30, 2011	Substantially Equivalent	GE HEALTHCARE INTEGRATED IT SOLUTIONS
K112354	5MP MONOCHROME LCD MONITOR, RADIFORCE GX530	Nov 30, 2011	Substantially Equivalent	EIZO NANAO CORPORATION
K113029	SYNGO VIA MI WORKFLOWS	Nov 18, 2011	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K112531	VITREA CT MYOCARDIAL ANALYSIS	Nov 18, 2011	Substantially Equivalent	VITAL IMAGES, INC.
K111642	ONCO TRAC MODEL 1, 2, 4	Nov 18, 2011	Substantially Equivalent	TRANSLATIONAL SCIENCES CORPORATION
K110596	MW100 (MAMMOGRAPHY) LCD MONITOR SYSTEM	Nov 18, 2011	Substantially Equivalent	WIDE CORPORATION
K112145	MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2	Nov 07, 2011	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K111161	PERFSCAPE V2.0	Nov 04, 2011	Substantially Equivalent	OLEA MEDICAL
K110765	FXA (TM)	Nov 04, 2011	Substantially Equivalent	ACES GMBH
K100784	UC-CARE NAVIGO SYTEM	Nov 01, 2011	Substantially Equivalent	UC-CARE LTD.
K112604	21.3 INCH (54 CM) COLOR LCD MONITOR CCL356I2 (CL21356)	Oct 27, 2011	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K112466	4MP COLOR LCD MONITOR, RADIFORCERX430	Oct 27, 2011	Substantially Equivalent	EIZO NANAO CORPORATION
K112974	PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM	Oct 20, 2011	Substantially Equivalent	CURVE DENTAL, INC.
K110919	CARESTREAM PACS	Oct 20, 2011	Substantially Equivalent	CARESTREAM HEALTH, INC.
K112439	SYNAPSE WORKSTATION SOFTWARE VERSION 3.3.0	Oct 17, 2011	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K111990	CORONIS 5MP	Oct 17, 2011	Substantially Equivalent	BARCO NV
K112051	LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE	Oct 12, 2011	Substantially Equivalent	BRONCUS TECHNOLOGIES, INC.
K112530	3DI INCLUDING CSCORE	Sep 30, 2011	Substantially Equivalent	SHINA SYSTEMS LTD.
K112096	IMAGELINK	Sep 30, 2011	Substantially Equivalent	COMPUTER PROGRAMS AND SYSTEMS, INC.
K111019	SURGIMAP (TM) SPINE	Sep 30, 2011	Substantially Equivalent	NEMARIS INC
K111641	SURGICASE ORTHOGNATHIC SOFTWARE WIZARD	Sep 26, 2011	Substantially Equivalent	MATERIALISE N.V.
K111496	21.3 INCH (54CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR	Sep 26, 2011	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K111989	CORONIS FUSION 4MP DL	Sep 22, 2011	Substantially Equivalent	BARCO NV
K111833	VIRTUE	Sep 21, 2011	Substantially Equivalent	DIAGNOSOFT, INC.
K111731	MOLECULAR BREAST IMAGING SOFTWARE	Sep 15, 2011	Substantially Equivalent	GAMMA MEDICA-IDEAS INCORPORATED
K111694	ASTRA	Sep 15, 2011	Substantially Equivalent	CANDELIS, INC.
K110033	FEEL-DRCS	Sep 15, 2011	Substantially Equivalent	IMFOU CO., LTD
K101898	R4 ACERT ULTRASOUND REPORTING SYSTEM	Sep 15, 2011	Substantially Equivalent	R4 LLC
K111660	XELIS CARDIAC	Sep 13, 2011	Substantially Equivalent	INFINITT CO., LTD.
K111346	RESOLUTIONMD MOBILE MODEL RMB-MOB-2X	Sep 09, 2011	Substantially Equivalent	CALGARY SCIENTIFIC, INC.
K111613	XELIS FUSION	Sep 08, 2011	Substantially Equivalent	INFINITT CO., LTD.
K103308	AIDA HD CONNECT WITH SMARTSCREEN / BLU-RAY DRIVE / SMARTSCREEN WITH BLU-RAY DRIVE	Aug 29, 2011	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K103181	ZENIS, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM	Aug 26, 2011	Substantially Equivalent	GENORAY CO., LTD.
K111373	CT42 CARDIAC COMPUTED TOMOGRAPHY (CT) SOFTWARE	Aug 23, 2011	Substantially Equivalent	CIRCLE CARDIOVASCULAR IMAGING INC.
K111991	NIO COLOR 2MP	Aug 11, 2011	Substantially Equivalent	BARCO NV
K102078	RADIOLOGICAL IMAGE PROCESSING SYSTEM	Aug 10, 2011	Substantially Equivalent	VATECH CO., LTD.
K111945	IMPAX NEXT GENERATION	Aug 05, 2011	Substantially Equivalent	AGFA HEALTHCARE N.V.
K111319	IBIS EXPLORER AND MARKUP SOFTWARE	Aug 05, 2011	Substantially Equivalent	MEDQIA
K111245	HEARTNAVIGATOR RELEASE 1	Jul 29, 2011	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K111892	VITREAVIEW SOFTWARE 6.1	Jul 28, 2011	Substantially Equivalent	VITAL IMAGES, INC.
K111804	INTELLISPACE PACS 4.X	Jul 28, 2011	Substantially Equivalent	PHILIPS HEALTHCARE INFORMATICS, INC.
K111222	MRI-Q SYSTEM	Jul 28, 2011	Substantially Equivalent	RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
K103130	XELIS 3D	Jul 28, 2011	Substantially Equivalent	INFINITT CO., LTD.
K110797	COMMUNIFY PACS VIEWER	Jul 20, 2011	Substantially Equivalent	FLYING SQUIRREL STORAGE LLC
K110300	SIMPLANT 2011	Jul 01, 2011	Substantially Equivalent	MATERIALISE DENTAL NV
K110886	CLIO/CLIOSOFT	Jun 30, 2011	Substantially Equivalent	SOTA PRECISION OPTICS, INC.
K111638	IMPAX VOLUME VIEWING	Jun 24, 2011	Substantially Equivalent	AGFA HEALTHCARE N.V.
K110414	QLAB 8.1 QUANTIFICATION SOFTWARE	Jun 21, 2011	Substantially Equivalent	PHILIPS ULTRASOUND, INC.
K111237	MD301C4 29.8 DIAGNOSTIC IMAGING LCD MONITOR, L309TY	Jun 15, 2011	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K103724	10 MP GRAYSCALE FLAT PANEL DISPLAY (GX 1030)	Jun 08, 2011	Substantially Equivalent	EIZO GMBH
K110447	ECHOINSIGHT	May 27, 2011	Substantially Equivalent	ULTRASOUND MEDICAL DEVICES, INC.
K111336	EBW NM 2.0	May 24, 2011	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
K102534	AZE VIRTUALPLACE-MR FLOW ANALYSIS SOFTWARE	May 24, 2011	Substantially Equivalent	AZE, LTD.
K111052	SYNGO NEURO PBV-IR	May 20, 2011	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K103723	SICAT IMPLANT V1.2	May 20, 2011	Substantially Equivalent	SICAT GMBH & CO. KG
K111079	SYNGO.VIA WEB VIEWER	May 13, 2011	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K110430	DOLPHIN IMAGING	May 11, 2011	Substantially Equivalent	PATTERSON DENTAL SUPPLY, INC.
K111164	EUNITY	May 06, 2011	Substantially Equivalent	CLIENT OUTLOOK INC
K111102	RADIOVISION	May 05, 2011	Substantially Equivalent	HAAS SOFTWARE
K110875	CENTRICITY PACS	May 05, 2011	Substantially Equivalent	GE HEALTHCARE
K110573	READY VIEW	May 03, 2011	Substantially Equivalent	GE HEALTHCARE (GE MEDICAL SYSTEMS SCS)
K110834	AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION	Apr 26, 2011	Substantially Equivalent	GE HEALTHCARE
K111024	JETPACK 2.0	Apr 21, 2011	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS (CLEVELAND), INC.
K110139	CURVE IMAGE	Apr 21, 2011	Substantially Equivalent	CURVE DENTAL, INC.
K110844	SYMBIA.NET	Apr 20, 2011	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K103565	MEDVOXEL HEARTPRO SOFTWARE APPLICATION	Apr 12, 2011	Substantially Equivalent	MEDVOXEL SYSTEMS INC
K110667	IMAGE-ARENA AND IMAGE-ARENA APPLICATIONS	Apr 08, 2011	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K110595	4D SONO-SCAN 1.0	Apr 07, 2011	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K110186	SYNAPSE 3D LIVER ANALYSIS	Apr 07, 2011	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K110494	SYNGO MBF	Apr 06, 2011	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K110332	CLEARCANVAS RIS / PACS	Mar 24, 2011	Substantially Equivalent	CLEARCANVAS INC.
K103546	AYCAN WORKSTATION OSIRIX PRO	Mar 17, 2011	Substantially Equivalent	AYCAN DIGITALSYSTEME GMBH
K110108	MODALIXX	Mar 16, 2011	Substantially Equivalent	AMPRONIX, INC.
K103720	SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS	Mar 16, 2011	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K110511	E4D COMPASS	Mar 11, 2011	Substantially Equivalent	D4D TECHNOLOGIES
K103480	THORACIC VCAR	Mar 07, 2011	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K103792	BARCO MAMMO TOMOSYNTHESIS	Mar 04, 2011	Substantially Equivalent	BARCO NV
K103687	SYNAPSE 3D CEREBRAL ANALYSIS	Mar 04, 2011	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K103458	VIEWPOINT 6	Mar 04, 2011	Substantially Equivalent	GE HEALTHCARE
K103679	AXIS PACS, HMS PACS	Mar 03, 2011	Substantially Equivalent	AXIS HEALTH CARE, LLC
K103576	MIM 5.2 (BRACHY)	Feb 18, 2011	Substantially Equivalent	MIM SOFTWARE INC.
K103761	VISUALIZE: VASCULAR	Feb 11, 2011	Substantially Equivalent	THE MEDIPATTERN CORPORATION
K103785	MOBILE MIM	Feb 04, 2011	Substantially Equivalent	MIM SOFTWARE INC.
K101842	ACIES	Feb 04, 2011	Substantially Equivalent	KONICA MINOLTA MEDICAL & GRAPHIC, INC.
K101398	STEREOS WORKSTATION	Feb 04, 2011	Substantially Equivalent	BIOSPACE MED
K103385	SECURVIEW DX DIAGNOSTIC WORKSTATION	Feb 02, 2011	Substantially Equivalent	HOLOGIC, INC.
K110071	COR ANALYZER	Jan 31, 2011	Substantially Equivalent	RCADIA MEDICAL IMAGING LTD.
K103465	SYNAPSE 3D CARDIAC TOOLS	Jan 31, 2011	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K110077	NEUCOLONCARE	Jan 28, 2011	Substantially Equivalent	NEUSOFT MEDICAL SYSTEMS CO., LTD.
K110040	OMNIVISION	Jan 26, 2011	Substantially Equivalent	MODERN MODULE INC
K103815	Q-STATION	Jan 25, 2011	Substantially Equivalent	PHILIPS ULTRASOUND, INC.
K103182	TRIANA, PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM	Jan 14, 2011	Substantially Equivalent	GENORAY CO., LTD.
K103475	SPINEANALYER MODEL SAPOC	Jan 05, 2011	Substantially Equivalent	OPTASIA MEDICAL
K100372	SAFECT MODEL VER 1.0	Dec 14, 2010	Substantially Equivalent	MEDIC VISION BRAIN TECHNOLOGIES LTD
K100837	PACENTRIC CONNECT, TRAVELER AND WEB	Dec 03, 2010	Substantially Equivalent	FIMREITE SOFTWARE AS
K102849	ACCULMAING	Nov 23, 2010	Substantially Equivalent	RADIOLOGY INFORMATION SYSTEMS, INC.
K092728	20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A)	Nov 19, 2010	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K101654	IMPROVIS IMAGING SYSTEM	Nov 10, 2010	Substantially Equivalent	AMERICAN DENTAL PARTNERS, INC
K101707	FULACCESS MODEL 1.0	Oct 29, 2010	Substantially Equivalent	FULCRUM MEDICAL, INC
K102435	BEYONDIMAGE WORKSTATION	Oct 15, 2010	Substantially Equivalent	NEUSOFT MEDICAL SYSTEMS CO., LTD.
K102000	IMAGYS	Oct 12, 2010	Substantially Equivalent	KEOSYS S.A.S.
K102556	VOLPARA, VERSION 1.3	Oct 07, 2010	Substantially Equivalent	MATAKINA TECHNOLOGY LIMITED
K101166	4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ	Oct 07, 2010	Substantially Equivalent	GE HEALTHCARE
K102150	SYNGO DYNAMICS, VERSION 9.0	Oct 05, 2010	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K101324	GE ECHOPAC MODEL BT10	Oct 05, 2010	Substantially Equivalent	GE VINGMED ULTRASOUND AS
K102687	MIRADA RT	Oct 04, 2010	Substantially Equivalent	MIRADA MEDICAL LTD.
K102684	XELIS DENTAL	Oct 01, 2010	Substantially Equivalent	INFINITT CO., LTD.
K101311	EP NAVIGATOR R3	Sep 30, 2010	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K101697	ENSITE VERISMO SEGMENTATION TOOL V.2.0	Sep 22, 2010	Substantially Equivalent	ST. JUDE MEDICAL
K100793	UROSTATION 3D PROSTATE SUITE	Sep 22, 2010	Substantially Equivalent	KOELIS
K101342	OSIRIX MD	Aug 20, 2010	Substantially Equivalent	PIXMEO SARL
K093269	PROCEDURE REHEARSAL STUDIO	Aug 20, 2010	Substantially Equivalent	SIMBIONIX LTD.
K102148	CURIEPACS (DICOM PACS SOFTWARE)	Aug 17, 2010	Substantially Equivalent	MOKSHA DIGITAL SOFTWARE PVT LIMITED
K101749	SYNGO TRUED SOFTWARE	Aug 16, 2010	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS
K090947	21.3 (54 CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR, MODEL MS3112 (MDL2128A)	Aug 16, 2010	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD.
K101666	SYNGO. PLAZA VA20A	Aug 10, 2010	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K101279	CORRIDOR4DM V2010 MODEL: V2010	Aug 04, 2010	Substantially Equivalent	INVIA
K101662	SYNAPSE 3D BASIC TOOLS	Jul 26, 2010	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K092328	MED-SEG, MODEL BTMS 1000	Jul 26, 2010	Substantially Equivalent	BARTRON MEDICAL IMAGING, INC.
K101796	PACSMATE MMD-5201M MONITOR	Jul 15, 2010	Substantially Equivalent	IEI TECHNOLOGY CORP.
K101228	MIRADA XD	Jun 23, 2010	Substantially Equivalent	MIRADA MEDICAL LTD.
K093197	CORONIS FUSION 10MP, MODEL MDCG-10130	Jun 23, 2010	Substantially Equivalent	BARCO NV
K092915	CEDARA WEBACCESS, MODEL: 2.4	Jun 23, 2010	Substantially Equivalent	CEDARA SOFTWARE CORP.
K100619	SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827	May 07, 2010	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA INC.
K100292	CAAS QVA 3D, CAAS QCA 3D	Apr 30, 2010	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K094064	ILUMA VISION MODEL VERSION 2.2	Apr 30, 2010	Substantially Equivalent	3M IMTEC
K100881	SYNAPSE OBLIQUUS MIP/MPR/FUSION	Apr 14, 2010	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K100335	ORS VISUAL	Apr 08, 2010	Substantially Equivalent	OBJECT RESEARCH SYSTEMS, INC.
K100236	STAIR SYSTEMS PACS & DICOM VIEWER	Mar 29, 2010	Substantially Equivalent	STAIR SYSTEMS, INC.
K093603	STORM-BASE 2.0	Mar 18, 2010	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K092363	SOFTVIEW, MODEL 2.01	Mar 18, 2010	Substantially Equivalent	RIVERAIN MEDICAL GROUP
K091631	ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW	Mar 18, 2010	Substantially Equivalent	ASPYRA, INC.
K092427	SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION)	Mar 16, 2010	Substantially Equivalent	ALBERT DAVYDOV DDS PC PROFESSIONAL
K100094	CARESTREAM IMAGE SUITE	Mar 11, 2010	Substantially Equivalent	CARESTREAM HEATLH, INC.
K093480	CUATTRO UNOMD	Mar 05, 2010	Substantially Equivalent	CUATTRO, LLC
K090050	STEREOS WORKSTATION	Mar 05, 2010	Substantially Equivalent	BIOSPACE MED
K093612	SYNGO.PLAZA	Mar 04, 2010	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K092613	COLOR LCD MONITOR, MODEL RADIFORCE RS210	Mar 03, 2010	Substantially Equivalent	EIZO NANAO CORPORATION
K092842	ECHOPLAQUE	Mar 01, 2010	Substantially Equivalent	INDEC SYSTEMS, INC.
K093621	SYNGO.PET&CT ONCOLOGY	Feb 23, 2010	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K093444	EXAPACS	Feb 04, 2010	Substantially Equivalent	MEDINCOM TECHNOLOGY CORP
K093703	3DI	Jan 19, 2010	Substantially Equivalent	SHINA SYSTEMS LTD.
K093982	XELERIS 3 PROCESSING AND REVIEW WORKSTATION	Jan 08, 2010	Substantially Equivalent	GE MEDICAL SYSTEMS F.I. HAIFA
K093355	PCR ELEVA 1.2	Jan 08, 2010	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K093090	GALILEOS IMPLANT, VERSION 1.7	Dec 17, 2009	Substantially Equivalent	SICAT GMBH & CO. KG
K093672	AEGIS NAVIGATION ANDA EGIS PELVIC APPLICATION	Dec 11, 2009	Substantially Equivalent	SENTINELLE MEDICAL, INC.
K093117	DIGITAL LIGHTBOX	Dec 11, 2009	Substantially Equivalent	BRAINLAB AG
K091364	DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4	Dec 11, 2009	Substantially Equivalent	OEHM UND REHBEIN GMBH
K092125	PRESIDIO PACS	Dec 10, 2009	Substantially Equivalent	REAONIX SECURITY, LLC
K093247	MEDSYNAPSE PACS SOFTWARE	Dec 02, 2009	Substantially Equivalent	MEDSYNAPTIC PRIVATE, LTD.
K092639	INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP	Dec 02, 2009	Substantially Equivalent	GE MEDICAL SYSTEMS SCS
K093423	LUNGPOINT PROCEDURE PLANNING	Nov 17, 2009	Substantially Equivalent	BRONCUS TECHNOLOGIES, INC.
K092741	COLOR LCD MONITOR, MODEL RADIFORCE MX241W	Nov 10, 2009	Substantially Equivalent	EIZO NANAO CORPORATION
K092954	CADSTREAM VERSION 5	Nov 06, 2009	Substantially Equivalent	CONFIRMA, INC.
K093234	INTEGRATED REGISTRATION	Oct 30, 2009	Substantially Equivalent	GE MEDICAL SYSTEMS SCS
K092581	MITS DICOM GATEWAY AND IMAGE MANAGER	Oct 30, 2009	Substantially Equivalent	MITSMED MEDICAL INSTRUMENT TECHNOLOGY CO., LTD.
K092949	IMAGEGRID RADIOLOGY VIEWER SYSTEM	Oct 08, 2009	Substantially Equivalent	CANDELIS, INC.
K092204	PMD VIEWER	Oct 08, 2009	Substantially Equivalent	SPENCER TECHNOLOGIES
K092067	ABVS WORKPLACE	Sep 18, 2009	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K092134	STAT PACS PICTURE ARCHIVING & COMMUNICATION SYSTEM (PACS)	Sep 15, 2009	Substantially Equivalent	STATRAD, LLC
K092519	SYNGO.X	Aug 27, 2009	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K092102	NORDICBRAINEX SOFTWARE, VERSION 1.0	Aug 25, 2009	Substantially Equivalent	NORDICIMAGINGLAB AS
K092235	BEYONDIMAGE WORKSTATION	Aug 06, 2009	Substantially Equivalent	NEUSOFT MEDICAL SYSTEMS CO., LTD.
K092081	QXLINK	Jul 21, 2009	Substantially Equivalent	VIEWORKS CO., LTD.
K091274	CORONIS 5MP HD, MODEL MDMG 5121	Jul 14, 2009	Substantially Equivalent	BARCO NV
K091687	PACSMATE, MODEL MMD-4300C/MMD-4300CX	Jul 07, 2009	Substantially Equivalent	IEI TECHNOLOGY CORP.
K083658	PACS PLUS 5TH EDITION	Jul 07, 2009	Substantially Equivalent	MEDICAL STANDARD CO., LTD.
K091262	MR CARDIAC FUNCTION ANALYSIS	Jun 29, 2009	Substantially Equivalent	ZIOSOFT, INC.
K091001	MYRIAN 1.4	Jun 29, 2009	Substantially Equivalent	INTRASENSE
K090668	VISION TOOLS	Jun 23, 2009	Substantially Equivalent	MILLENSYS
K083520	INTELEPACS, MODEL VERSION 3.X.X	Jun 23, 2009	Substantially Equivalent	INTELERAD MEDICAL SYSTEMS INCORPORATED
K091032	CERNER PROVISION WORKSTATION (VERSION 2.5)	Jun 22, 2009	Substantially Equivalent	CERNER CORP.
K090431	DEXIS SOFTWARE	Jun 22, 2009	Substantially Equivalent	DEXIS LLC
K090546	MODIFICATION TO NORDICICE SOFTWARE	Jun 08, 2009	Substantially Equivalent	NORDICIMAGINGLAB AS
K091498	VITREA ENDOVASCULAR STENT PLANNING SOFTWARE	Jun 05, 2009	Substantially Equivalent	VITAL IMAGES, INC.
K091368	R2 DIGITALNOW HD(DIGITALNOW HD)	Jun 04, 2009	Substantially Equivalent	HOLOGIC, INC.
K090461	IMAGE-ARENA 4.0 AND IA APPLICATIONS 2D CARDIAC PERFORMANCE ANALYSIS 1.0	May 22, 2009	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K090155	CAAS MR FLOW 1.0	May 22, 2009	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K091373	SYNGO TRUED	May 20, 2009	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K083327	SYNGOCIRCULATION DYNAMICPET, VERSION 1.0	May 18, 2009	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K091286	SYNGO US WORKPLACE	May 15, 2009	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K090833	SEGMENT	May 12, 2009	Substantially Equivalent	MEDVISO
K091172	NIO 2MP (MDNG-2121)	May 05, 2009	Substantially Equivalent	BARCO NV
K091160	LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM	May 05, 2009	Substantially Equivalent	BRONCUS TECHNOLOGIES, INC.
K090607	BLUE SKY BIO PLAN, VERSION .38	Apr 22, 2009	Substantially Equivalent	BLUE SKY BIO, LLC
K090603	BARCO 5MP MAMMO, MODEL MDMG-5221	Apr 22, 2009	Substantially Equivalent	BARCO NV
K090732	NIO COLOR 3MP AND MDNC-3121	Apr 20, 2009	Substantially Equivalent	BARCO NV
K090218	MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ	Apr 15, 2009	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K090215	MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL	Apr 15, 2009	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K083910	VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER	Apr 15, 2009	Substantially Equivalent	VIDISTAR, LLC
K090223	ICAD BREAST INTERVENTIONAL PLANNING SOFTWARE, MODEL D70024	Mar 31, 2009	Substantially Equivalent	ICAD, INC.
K083446	CARDIAC FUNCTION ANALYSIS, CALCIUM SCORING	Mar 31, 2009	Substantially Equivalent	ZIOSOFT, INC.
K090649	VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE	Mar 27, 2009	Substantially Equivalent	VIRTUAL RADIOLOGIC CORPORATION
K081168	BRIT PACS SYSTEMS	Mar 23, 2009	Substantially Equivalent	BRIT SYSTEMS, INC.
K090481	DEMASQ IMAGING SPFTWARE DEVICE	Mar 19, 2009	Substantially Equivalent	DEMASQ LIMITED
K090552	UROCARE	Mar 16, 2009	Substantially Equivalent	NEUSOFT MEDICAL SYSTEMS CO., LTD.
K090095	LUNGPOINT VIRTUAL BRONCHOSCOPIC NAVIGATION VBN SYSTEM	Mar 13, 2009	Substantially Equivalent	BRONCUS TECHNOLOGIES, INC.
K090295	BODYVIZ, MODEL 100	Mar 04, 2009	Substantially Equivalent	VISUAL MEDICAL SOLUTIONS, LLC
K083182	DATACOM DC PACS	Mar 04, 2009	Substantially Equivalent	DATACOM TECHNOLOGY CORP.
K083691	BONEVUE	Feb 25, 2009	Substantially Equivalent	MICROMRI, INC.
K082623	VISIX IMAGING	Feb 25, 2009	Substantially Equivalent	TELEVERE SYSTEMS
K082693	RESOLUTIONMD, RELEASE 2.1	Feb 23, 2009	Substantially Equivalent	CALGARY SCIENTIFIC, INC.
K083491	NEUROSCAPE	Feb 19, 2009	Substantially Equivalent	OLEA MEDICAL
K083740	MAMMODIAGNOST VU	Feb 13, 2009	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K090119	SICAT IMPLANT	Feb 05, 2009	Substantially Equivalent	SICAT GMBH & CO. KG
K081556	CADSTREAM, VERSION 5.0	Feb 02, 2009	Substantially Equivalent	CONFIRMA, INC.
K090045	COLOR LCD MONITOR, RADIFORCE RX320	Jan 28, 2009	Substantially Equivalent	EIZO NANAO CORPORATION
K083618	PACS SCAN	Jan 28, 2009	Substantially Equivalent	PACSGEAR, INC.
K083916	LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD	Jan 14, 2009	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K083149	ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE	Jan 14, 2009	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K083907	MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG	Jan 13, 2009	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K083332	MD21M 21.3 DIAGNOSTIC IMAGING LCD MONITOR, MODEL L218TK	Jan 09, 2009	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K082808	IMAGESVR PACS	Jan 09, 2009	Substantially Equivalent	JAGUAR TECHNOLOGY LIMITED
K082526	CARDIO VUE QUANTITATIVE ANALYSIS (CVQ)	Jan 05, 2009	Substantially Equivalent	MRI CARDIAC SERVICES, INCORPORATED
K083673	CARESTREAM PACS, MODEL CARESTREAM PACS VII	Dec 30, 2008	Substantially Equivalent	CARESTREAM HEALTH, INC.
K083348	IMAGE-ARENA APPLICATIONS	Dec 23, 2008	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K083084	CT BRAIN PERFUSION FOR ZIOSTATION	Dec 19, 2008	Substantially Equivalent	ZIOSOFT, INC.
K083555	PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION	Dec 16, 2008	Substantially Equivalent	EMSOMA CO., LTD.
K082269	VISAGE PACS, VERSION 6.0/CS 3.1	Dec 12, 2008	Substantially Equivalent	VISAGE IMAGING, INC.
K082607	MRI-PLAQUE VIEW, VERSION 1.1.2003	Dec 05, 2008	Substantially Equivalent	VPDIAGNOSTICS, INC
K082441	NORDICICE SOFTWARE	Nov 21, 2008	Substantially Equivalent	NORDICIMAGINGLAB AS
K082990	INFINITT XELIS	Nov 20, 2008	Substantially Equivalent	INFINITT CO., LTD.
K082628	CMR42 CARDIAC MRI IMAGING SYSTEM, 2.1.23	Nov 20, 2008	Substantially Equivalent	CIRCLE CARDIOVASCULAR IMAGING INC.
K082240	SNTRYPACS	Nov 20, 2008	Substantially Equivalent	QSTAR TECHNOLOGIES, INC.
K083018	CENTRICITY PACS WEB DIAGNOSTIC	Nov 14, 2008	Substantially Equivalent	GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS
K082430	SYNGO IMAGING XS	Nov 14, 2008	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K082706	INFINITT CARDIOLOGY PACS	Nov 06, 2008	Substantially Equivalent	INFINITT CO., LTD.
K082493	MEDICAL DISPLAY, MD205MG-1	Oct 23, 2008	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K082135	SHOWCASE	Oct 21, 2008	Substantially Equivalent	TRILLIUM TECHNOLOGY, INC
K082336	XR-EXPRESS	Oct 15, 2008	Substantially Equivalent	NEW MEXICO SOFTWARE, INC.
K082684	4D VIEWER RADIOLOGY, MODEL USWP-100A	Oct 14, 2008	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K082663	COLOR LCD MONITOR	Oct 06, 2008	Substantially Equivalent	EIZO NANAO CORPORATION
K082510	IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0	Oct 01, 2008	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K081987	UNISYN IMAGE FUSION, VERSION 1.0	Sep 26, 2008	Substantially Equivalent	CONVERGENT IMAGING SOLUTIONS
K081985	AW SERVER	Sep 25, 2008	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K082596	ULTRAEXTEND USWS-900A	Sep 23, 2008	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K082228	PLANISIGHT LINASYS	Sep 22, 2008	Substantially Equivalent	PATHFINDER THERAPEUTICS, INC.
K081948	RAYPAX SYSTEM	Sep 19, 2008	Substantially Equivalent	RAYPAX, INC.
K081792	SPY ANALYSIS TOOLKIT, MODEL SA9000	Sep 17, 2008	Substantially Equivalent	NOVADAQ TECHNOLOGIES, INC.
K082386	INREACH PLANNING LAPTOP	Sep 16, 2008	Substantially Equivalent	SUPERDIMENSION, LTD.
K082483	QUANTRA	Sep 12, 2008	Substantially Equivalent	HOLOGIC, INC.
K081945	21.3-INCH (54CM) MONOCHROME LCD MONITOR MS21I2 (MDL2127A)	Sep 12, 2008	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K081656	VISUALASE THERMAL THERAPY SYSTEM	Sep 10, 2008	Substantially Equivalent	BIOTEX, INC.
K082496	PACSMATE MMD-3213M MONITOR	Sep 09, 2008	Substantially Equivalent	IEI TECHNOLOGY CORP.
K082144	AMICAS PACS, VERSION 6.0	Sep 05, 2008	Substantially Equivalent	AMICAS, INC.
K081357	5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9)	Sep 05, 2008	Substantially Equivalent	EIZO GMBH
K080196	Z3D CONTRAST ACUITY	Sep 05, 2008	Substantially Equivalent	CLARIO MEDICAL IMAGING, INC.
K082341	DSA 2000EX	Aug 29, 2008	Substantially Equivalent	EIGEN LLC
K080529	STEREOS WORKSTATION	Aug 29, 2008	Substantially Equivalent	BIOSPACE MED
K081215	VOLUMINA	Aug 26, 2008	Substantially Equivalent	KJAYA MEDICAL, LLC
K082318	CENTRICITY PACS IW	Aug 25, 2008	Substantially Equivalent	GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS
K081672	C-INSIGHT	Aug 15, 2008	Substantially Equivalent	MAZOR SURGICAL TECHNOLOGIES LTD.
K081752	EDGE PACS	Aug 06, 2008	Substantially Equivalent	ASHVA TECHNOLOGIES, PVT. LTD
K082041	FIATLUX VISUALIZE	Aug 01, 2008	Substantially Equivalent	FIATLUX IMAGING INC.
K081630	MAMMO WORKSTATION	Jul 29, 2008	Substantially Equivalent	IMAGE DIAGNOST INTERNATIONAL GMBH
K081976	IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION	Jul 28, 2008	Substantially Equivalent	AGFA HEALTHCARE CORPORATION
K081512	STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE	Jul 18, 2008	Substantially Equivalent	MEDTRONIC NAVIGATION, INC.
K081402	SIMPLANT ORTHO ; VISTADENT 3D	Jul 18, 2008	Substantially Equivalent	MATERIALISE DENTAL NV
K080905	QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI	Jul 16, 2008	Substantially Equivalent	QUANTUM MEDICAL IMAGING, LLC.
K081843	ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1	Jul 15, 2008	Substantially Equivalent	ALOKA CO., LTD.
K081734	SYNGO IMAGING (VERSION V31)	Jul 03, 2008	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K081076	VELOCITYAIS, VELOCITY AI, VELOCITYVX, VELOCITYRT, V-RESPONSE	Jun 20, 2008	Substantially Equivalent	VELOCITY MEDICAL SOLUTIONS, LLC
K081262	DC NEURO	Jun 17, 2008	Substantially Equivalent	INVIVO CORPORATION
K081469	SECTRA WORKSTATION, IDS7 VERSION 11.3, IDS5 VERSION 11.1 P2	Jun 12, 2008	Substantially Equivalent	SECTRA IMTEC AB
K081304	ALZ WEB PACS, VERSION 1.0	Jun 11, 2008	Substantially Equivalent	ALZ, INC.
K081242	21.3 INCH (53CM) MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS51I2, (MDL2123A)	Jun 11, 2008	Substantially Equivalent	TOKOTU ELECTRIC CO., LTD.
K081308	FUJIFILM FCR VIEW, MODEL CR-VW674	Jun 04, 2008	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
K081056	21.3 (54CM) 3M COLOR LCD MONITOR CCL354I2 (CDL2126A)	Jun 04, 2008	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD.
K081055	21.3 (54CM) 2M COLOR LCD MONITOR CCL254I2 (CDL2125A)	Jun 04, 2008	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD.
K080952	15-INCH (38 CM) COLOR LCD MONITOR CDL1576A	May 29, 2008	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K080951	19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A	May 29, 2008	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K081347	ILUMA VISION	May 28, 2008	Substantially Equivalent	IMTEC CORP.
K072258	BI-RADS COMPANION	May 16, 2008	Substantially Equivalent	ALMEN LABORATORIES, INC.
K081109	CORONIS 5MP MAMMO SL, MODEL MDMG 6121	May 02, 2008	Substantially Equivalent	BARCOVIEW, MEDICAL IMAGING SYSTEMS
K081093	3-D IMAGING WORKSTATION	May 01, 2008	Substantially Equivalent	EIGEN LLC
K080890	SMARTSPOT PRIMAX	Apr 29, 2008	Substantially Equivalent	CMT MEDICAL TECHNOLOGIES, LTD.
K081018	SYNGO DYNAMICS VERSION 7.0	Apr 25, 2008	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS
K073358	LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A	Apr 25, 2008	Substantially Equivalent	HEEYOUNG CO., LTD.
K080351	DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI	Apr 22, 2008	Substantially Equivalent	DEXELA LTD
K072728	SYNGO MULTIMODALITY WORKPLACE	Apr 22, 2008	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K080961	NM APPLICATION SUITE	Apr 18, 2008	Substantially Equivalent	PHILIPS NUCLEAR MEDICINE, INC
K080608	DIGITAL LIGHTBOX	Apr 17, 2008	Substantially Equivalent	BRAINLAB, AG
K073449	SURGICASE	Apr 16, 2008	Substantially Equivalent	MATERIALISE N.V.
K080770	IMAGENMD WITH IMAGENQ	Apr 09, 2008	Substantially Equivalent	CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC
K080325	IGROK	Apr 08, 2008	Substantially Equivalent	IGROK, LLC
K073468	MIMICS	Apr 02, 2008	Substantially Equivalent	MATERIALISE N.V.
K080457	COLOR LCD MONITOR, MODEL RADIFORCE RX211	Mar 20, 2008	Substantially Equivalent	EIZO NANAO CORPORATION
K073714	TRAUMACAD VERSION 2.0	Mar 19, 2008	Substantially Equivalent	ORTHOCRAT, LTD.
K073176	KANTERON DICOM STATION (KDS), MODEL 3.0	Mar 19, 2008	Substantially Equivalent	MONICA VEYTIA
K073526	AMICAS VISION SERIES PACS, MODEL 5.5	Mar 12, 2008	Substantially Equivalent	AMICAS, INC.
K080422	5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520	Mar 10, 2008	Substantially Equivalent	EIZO NANAO CORPORATION
K073062	OMNI-VUE SYSTEM	Mar 10, 2008	Substantially Equivalent	GENESIS DIGITAL IMAGING, INC.
K073418	SYNGO IMAGING CCF VA10A	Feb 29, 2008	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K080333	IMAGEGRID	Feb 22, 2008	Substantially Equivalent	CANDELIS, INC.
K080290	XVIEWNET	Feb 22, 2008	Substantially Equivalent	AMERICAN RADIOLOGIST NETWORK, INC.
K080334	INSTARAD	Feb 21, 2008	Substantially Equivalent	MEDSPHERE TECHNOLOGIES PVT LTD.
K080320	PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300	Feb 21, 2008	Substantially Equivalent	NDS SURGICAL IMAGING
K073704	I-DIXEL	Feb 21, 2008	Substantially Equivalent	J. MORITA USA, INC.
K072821	VITREA 4DCT	Feb 20, 2008	Substantially Equivalent	VITAL IMAGES, INC.
K073194	CMRTOOLS AND PLUG-INS VENTRICULAR TOOLS & THALASSAEMIA TOOLS	Feb 14, 2008	Substantially Equivalent	CARDIOVASCULAR IMAGING SOLUTIONS LTD.
K073007	CORONIS FUSION 6MP DL, MODEL: MDCC 6130 DL	Feb 14, 2008	Substantially Equivalent	BARCOVIEW, MEDICAL IMAGING SYSTEMS
K071794	15M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2123A (MS51I2)	Feb 11, 2008	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K072653	3VISEON/SURGERY	Jan 24, 2008	Substantially Equivalent	3MENSIO MEDICAL IMAGING BV
K072875	NIO 5MP DISPLAY, MODEL E5620	Jan 22, 2008	Substantially Equivalent	BARCOVIEW, MEDICAL IMAGING SYSTEMS
K073292	MM/MMA/COLOR SERIES DIGITAL FLAT PANEL DISPLAY SYSTEM	Jan 18, 2008	Substantially Equivalent	HEEYOUNG CO., LTD.
K080013	REGISTRATION AND FUSION	Jan 17, 2008	Substantially Equivalent	AGFA HEALTHCARE CORPORATION
K073169	SCIMAGE PICOMENTERPRISE	Jan 09, 2008	Substantially Equivalent	SCIMAGE, INC.
K073306	XORANCONNECT	Jan 07, 2008	Substantially Equivalent	XORAN TECHNOLOGIES, INC.
K073448	MEDICAL DISPLAY, MD205MG	Dec 20, 2007	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K073259	XIDF-100A/B1 IMAGE PROCESSOR	Dec 20, 2007	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K073340	COLOR LCD MONITOR, FLEXSCAN MX300W	Dec 19, 2007	Substantially Equivalent	EIZO NANAO CORPORATION
K073205	NIO 5MP, MODEL MDNG-5121	Dec 19, 2007	Substantially Equivalent	BARCOVIEW, MEDICAL IMAGING SYSTEMS
K073272	WORKSTATIONONE BREAST IMAGING WORKSTATION	Dec 11, 2007	Substantially Equivalent	THREE PALM SOFTWARE, LLC
K072637	DIVO	Dec 11, 2007	Substantially Equivalent	A2D IMAGING LLC
K073271	ORTHOGON	Dec 05, 2007	Substantially Equivalent	AGFA HEALTHCARE CORPORATION
K072986	INTEGRADWEB PACS SYSTEM	Nov 20, 2007	Substantially Equivalent	GE HEALTHCARE
K072952	GE ECHOPAC	Nov 16, 2007	Substantially Equivalent	GENERAL ELECTRIC CO.
K072960	CDP 5000, MEDIA AND DISTRIBUTION CENTER, DIAGNET	Nov 08, 2007	Substantially Equivalent	CDP, LTD.
K072972	MEDSTREAMING MEDICAL OFFICE SOFTWARE	Nov 06, 2007	Substantially Equivalent	MEDSTREAMING, LLC
K072532	TRUEPIX LCD MEDICAL DISPLAY MONITOR, MODELS TX-5M, TX-3M, TX-2M	Nov 02, 2007	Substantially Equivalent	DOOYANG SYSTEMS INC
K072665	SUNIRAY 5.2	Oct 03, 2007	Substantially Equivalent	ORANGEDENTAL GMBH & CO. KG
K071964	MIM 4.1 (SEASTAR)	Sep 26, 2007	Substantially Equivalent	MIMVISTA CORP.
K072242	COR ANALYZER II, MODEL V1.7	Sep 11, 2007	Substantially Equivalent	RCADIA MEDICAL IMAGING LTD.
K071584	OASIS RELEASE 1.0	Aug 31, 2007	Substantially Equivalent	SEGAMI CORPORATION
K072205	VISAGE PACS/CS, RELEASE VERSION 5.0	Aug 29, 2007	Substantially Equivalent	MERCURY COMPUTER SYSTEMS, INC
K071492	FIRSTVIEW	Aug 28, 2007	Substantially Equivalent	RIVERAIN MEDICAL GROUP,LLC
K071894	XEBRA DICOM IMAGE BROWSER	Aug 16, 2007	Substantially Equivalent	HX TECHNOLOGIES, INC.
K072066	1.3M MONOCHROME LCD MONITOR MDL1908A	Aug 14, 2007	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K072065	20.8-INCH (53CM) COLOR LCD MONITOR CDL2119A (CCL352I2)	Aug 14, 2007	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K071636	CODIAGNOSTIX (R) 5.72	Aug 09, 2007	Substantially Equivalent	IVS SOLUTIONS AG
K063066	AXIS-V MONOCHROME 5 MP DISPLAY	Aug 03, 2007	Substantially Equivalent	NATIONAL DISPLAY SYSTEMS
K071972	ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS	Jul 30, 2007	Substantially Equivalent	AGFA HEALTHCARE CORP.
K071950	SYNGO TRUED	Jul 27, 2007	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K071602	IMAGIC V2.0	Jul 23, 2007	Substantially Equivalent	ASHVA TECHNOLOGIES, PVT. LTD
K071166	UNIWEB, VERSION 5.0	Jul 23, 2007	Substantially Equivalent	ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)
K071599	EASYGUIDE	Jul 11, 2007	Substantially Equivalent	KEYSTONE DENTAL, INC.
K071436	REGIUS UNITEA	Jun 27, 2007	Substantially Equivalent	KONICA MINOLTA MEDICAL & GRAPHIC, INC.
K062878	EZPACS, VERSION 3.0	Jun 27, 2007	Substantially Equivalent	ADVANCED IMAGING SOLUTIONS, LLC
K071297	IMPAX SE SIGMACOM CLIENT (PACS WORKSTATION)	Jun 22, 2007	Substantially Equivalent	AGFA HEALTHCARE CORP.
K071232	IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS	Jun 20, 2007	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K071241	LMS-LIVER	Jun 08, 2007	Substantially Equivalent	MEDIAN TECHNOLOGIES
K071086	RESOLUTIONMD CARDIAC PRODUCT FAMILY, MODEL: RELEASE 1.0	Jun 01, 2007	Substantially Equivalent	CALGARY SCIENTIFIC, INC.
K071362	VITAL CONNECT 4.1	May 30, 2007	Substantially Equivalent	VITAL IMAGES, INC.
K071331	VITREA VERSION 4.0	May 25, 2007	Substantially Equivalent	VITAL IMAGES, INC.
K063269	5MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2010-5NC	May 23, 2007	Substantially Equivalent	CHI LIN TECHNOLOGY CO., LTD.
K071114	SYNGO IMAGING (VERSION V30)	May 22, 2007	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K071054	RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4	May 22, 2007	Substantially Equivalent	VOLUME INTERACTIONS PTE LTD
K070831	VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION	May 22, 2007	Substantially Equivalent	BARCOVIEW MIS EDINBURGH
K070868	LMS-LUNG/TRACK	May 15, 2007	Substantially Equivalent	MEDIAN TECHNOLOGIES
K071000	MYRIAN	May 14, 2007	Substantially Equivalent	INTRASENSE
K070755	INTERWORKS	May 08, 2007	Substantially Equivalent	AVREO, INC.
K070726	NIO COLOR 3MP AND MDNC 3120	May 02, 2007	Substantially Equivalent	BARCOVIEW, MEDICAL IMAGING SYSTEMS
K070713	IMPLANT LOCATION SOFTWARE-T	May 02, 2007	Substantially Equivalent	TACTILE TECHNOLOGIES, LTD.
K063391	SAPHENEIA CLARITY	Apr 26, 2007	Substantially Equivalent	SAPHENEIA COMMERCIAL PRODUCTS AB
K070618	DICOMPACS, MODEL 5	Apr 25, 2007	Substantially Equivalent	OEHM UND REHBEIN GMBH
K070606	VISIO+CD VIEWER# KPSCDVE01	Apr 24, 2007	Substantially Equivalent	KEOSYS S.A.S.
K070954	PATIENTGALLERY IMAGING SOFTWARE	Apr 20, 2007	Substantially Equivalent	RASTER BUILDERS, INC.
K070397	DGSCOPE, RELEASE 1.0	Apr 13, 2007	Substantially Equivalent	SEGAMI CORPORATION
K070683	MIRAGE CEDARS OPTION	Apr 12, 2007	Substantially Equivalent	SEGAMI CORPORATION
K070803	INVIVODENTAL	Apr 06, 2007	Substantially Equivalent	ANATOMAGE, INC
K070796	CHILI PACS	Apr 06, 2007	Substantially Equivalent	CHILI GMBH
K070792	QLAB QUANTIFICATION	Apr 06, 2007	Substantially Equivalent	PHILIPS ULTRASOUND, INC.
K070394	CERNER PROVISION WORKSTATION	Mar 27, 2007	Substantially Equivalent	CERNER CORP.
K070205	ZIOSTATION	Mar 23, 2007	Substantially Equivalent	ZIOSOFT, INC.
K062621	NIO 5MP-21 AND MDNG-5121 CB	Mar 19, 2007	Substantially Equivalent	BARCOVIEW
K070464	ONDEMAND3D	Mar 16, 2007	Substantially Equivalent	CYBERMED, INC.
K070370	21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2122A	Mar 09, 2007	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K070226	CARDIOCT	Mar 09, 2007	Substantially Equivalent	SHINA SYSTEMS LTD.
K070089	SYNTERMED LIVE	Mar 02, 2007	Substantially Equivalent	SYNTERMED, INC.
K070248	VELOCITYAIS	Mar 01, 2007	Substantially Equivalent	VELOCITY MEDICAL SOLUTIONS, LLC
K070322	SYNGO DYNAMICS, VERSION 6.0	Feb 27, 2007	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K070131	RADIFORCE GX220 AND GS220 MONOCHROME LCD MONITORS	Feb 15, 2007	Substantially Equivalent	EIZO NANAO CORPORATION
K070244	AEGIS	Feb 09, 2007	Substantially Equivalent	SENTINELLE MEDICAL, INC.
K070122	MONOCHROME LCD MONITOR, MODEL RADIFORCE GX320	Feb 08, 2007	Substantially Equivalent	EIZO NANAO CORPORATION
K063730	DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0	Jan 31, 2007	Substantially Equivalent	VOLUME INTERACTIONS PTE LTD
K063846	EIGEN DSA 2000	Jan 26, 2007	Substantially Equivalent	EIGEN
K070080	INTELEPACS	Jan 24, 2007	Substantially Equivalent	INTELERAD MEDICAL SYSTEMS INC.
K063294	TOPACS	Jan 24, 2007	Substantially Equivalent	RADIOLOGICAL SPECIALISTS, INC.
K063548	COR ANALYZER 1, VERSION 1.4	Jan 22, 2007	Substantially Equivalent	RCADIA MEDICAL IMAGING LTD.
K063439	MEDICAL IMAGE MANAGEMENT DEVICES FOR VISION TOOLS	Jan 22, 2007	Substantially Equivalent	MTD, INC.
K063539	NORDIC IMAGE CONTROL AND EVALUATION (NICE) SOFTWARE, VERSION 2.1	Jan 17, 2007	Substantially Equivalent	NORDICICEMEDICAL AS
K063826	SYNGO MI APPLICATIONS 2007A	Jan 12, 2007	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K063781	PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE	Jan 05, 2007	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K063470	AYCAN WORKSTATION OSIRIX	Jan 05, 2007	Substantially Equivalent	AYCAN DIGITALSYSTEME GMBH
K062905	NIO FUSION 4MP; MDNC 4130	Dec 29, 2006	Substantially Equivalent	BARCOVIEW
K063628	CENTRICITY RADIOLOGY RA600, CARDIOLOGY CA1000 AND DIGITAL HARDCOPY	Dec 26, 2006	Substantially Equivalent	GE HEALTHCARE INTEGRATED IT SOLUTIONS
K063579	2MP MEDICAL COLOR REFERENCE DISPLAY, MODEL MDC2130-2HC	Dec 14, 2006	Substantially Equivalent	CHI LIN TECHNOLOGY CO., LTD.
K063505	VISUALASE ENVISION SOFTWARE SYSTEM	Dec 12, 2006	Substantially Equivalent	BIOTEX, INC.
K063392	IMCO-STAT	Dec 12, 2006	Substantially Equivalent	IMCO TECHNOLOGIES
K063337	OPAL-RAD	Dec 12, 2006	Substantially Equivalent	VIZTEK, INC.
K063253	RCHIVE PACS	Dec 12, 2006	Substantially Equivalent	SOBHA RENAISSANCE INFORMATION TECHNOLOGY PVT LTD
K063221	MEDWEB ADVANCED 3D WEB PACS	Dec 12, 2006	Substantially Equivalent	NEXSYS ELECTRONICS, INC.
K063200	20.1-INCH (51CM) COLOR LCD MONITOR CDL2010A (CCL204)	Dec 07, 2006	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K063153	NOVAPACS	Dec 07, 2006	Substantially Equivalent	NOVARAD CORP.
K063199	21.3-INCH (54CM) COLOR LCD MONITOR CDL2120A (CCL252I2)	Dec 04, 2006	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K063198	21.3-INCH (54CM) MONOCHROME LCD MONITOR MDL2121A (ME253I2)	Nov 30, 2006	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K063197	21.3 INCH (54CM) MONOCHROME LCD MONITOR MDL2118A (ME355I2)	Nov 30, 2006	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K063188	DEL-IMS	Nov 30, 2006	Substantially Equivalent	DEL MEDICAL IMAGING CORP.
K063344	CAAS QCA 3D	Nov 28, 2006	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K063327	ORTHOVIEW	Nov 22, 2006	Substantially Equivalent	MERDIAN TECHNIQUE, LTD.
K062985	IVUS ENHANCER	Nov 22, 2006	Substantially Equivalent	INDEC SYSTEMS, INC.
K062237	CADI, VERSION 4	Nov 20, 2006	Substantially Equivalent	SYNCA MARKETING, INC.
K062131	NIO 5MP-M-21 (NIO 5MP MAMMO); MDNG-5121 BB	Nov 17, 2006	Substantially Equivalent	BARCOVIEW
K063289	2MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-2NC	Nov 16, 2006	Substantially Equivalent	CHI LIN TECHNOLOGY CO., LTD.
K061696	IQQA-LIVER SOFTWARE	Nov 13, 2006	Substantially Equivalent	EDDA TECHNOLOGY, INC.
K063267	ISITE PACS, V 4. X	Nov 09, 2006	Substantially Equivalent	STENTOR INC., A PHILIPS MEDICAL SYSTEMS CO.
K063266	3MP MEDICAL MONOCHROME REFERENCE DISPLAY, MODEL MDM2130-3NC	Nov 09, 2006	Substantially Equivalent	CHI LIN TECHNOLOGY CO., LTD.
K063120	COLOR LCD MONITOR, RADIFORCE, MODEL RX210	Nov 09, 2006	Substantially Equivalent	EIZO NANAO CORPORATION
K063093	SECTRA WORKSTATION, VERSION 11.1	Nov 07, 2006	Substantially Equivalent	SECTRA IMTEC AB
K062757	XERON PACS	Nov 07, 2006	Substantially Equivalent	XERON HEALTHCARE CORP.
K063031	PRISM VIEW, MODEL	Nov 02, 2006	Substantially Equivalent	KYRON CLINICAL IMAGING, INC.
K063006	GE LOGIQ WORKS	Nov 02, 2006	Substantially Equivalent	GENERAL ELECTRIC CO.
K062743	UNISIGHT MAMMOGRAPHY VIEWER, MODEL 4.0	Oct 31, 2006	Substantially Equivalent	ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)
K062598	IMT.LAB SOFTWARE	Oct 31, 2006	Substantially Equivalent	ESAOTE EUROPE B.V.
K063107	3DNET SUITE	Oct 27, 2006	Substantially Equivalent	BIOTRONICS3D, LTD.
K062490	VISAGE PACS/CS, RELEASE VERSION 4.1	Oct 27, 2006	Substantially Equivalent	MERCURY COMPUTER SYSTEMS, INC
K062477	AMICAS VISION SERIES PACS, MODEL 4.3	Oct 27, 2006	Substantially Equivalent	AMICAS, INC.
K060836	VISTADENT OC - VERSION 4	Oct 27, 2006	Substantially Equivalent	DENTSPLY INTL., INC.
K063037	CENTARISONE RIS/PACS	Oct 18, 2006	Substantially Equivalent	CENTARISONE, LLC
K062054	5 MEGAPIXEL MONOCHROME LCD MONITOR, RADIFORCE GS510	Oct 06, 2006	Substantially Equivalent	EIZO NANAO CORPORATION
K062031	CHASE CARDIAC ANALYSIS SYSTEM	Sep 27, 2006	Substantially Equivalent	CHASE MEDICAL, LP
K062164	RESOLUTIONMD, VERSION 1.3	Sep 22, 2006	Substantially Equivalent	CALGARY SCIENTIFIC, INC.
K062163	MIMVIEWER	Sep 22, 2006	Substantially Equivalent	MIMVISTA CORP.
K062650	EP NAVIGATOR SOFTWARE	Sep 21, 2006	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K062488	IQ-SYSTEM PACS SYSTEM	Sep 19, 2006	Substantially Equivalent	IMAGE INFORMATION SYSTEMS, LTD.
K061972	CONNECT IMAGING PACS	Sep 18, 2006	Substantially Equivalent	CONNECT IMAGING, INC.
K061532	GENTLE COLON (REVISION 2.0)	Sep 18, 2006	Substantially Equivalent	RENDOSCOPY, INC.
K062229	CTC WORKSTATION, MODEL 2200	Sep 11, 2006	Substantially Equivalent	MEDICAL DIAGNOSTIC TECHNOLOGIES, INC.
K062062	VOYAGER PACS SYSTEM	Sep 11, 2006	Substantially Equivalent	VOYAGER IMAGING
K062059	AIE REGION OF INTEREST IMAGE ENHANCEMENT	Sep 06, 2006	Substantially Equivalent	ADVANCED IMAGE ENHANCEMENT
K061995	XCELERA	Sep 06, 2006	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K061961	ART LAB SOFTWARE	Sep 06, 2006	Substantially Equivalent	PIE MEDICAL
K061928	CORONIS COLOR 2MP AND MDCC 2121	Sep 05, 2006	Substantially Equivalent	BARCOVIEW
K061927	CORONIS COLOR 3MP AND MDCC 3120-DL	Sep 05, 2006	Substantially Equivalent	BARCOVIEW
K061924	CORONIS 3MP AND MDCG 3120-CB	Sep 05, 2006	Substantially Equivalent	BARCOVIEW
K062328	VITREAACCESS, VERSION 1.0	Aug 21, 2006	Substantially Equivalent	VITAL IMAGES, INC.
K061920	NOVAPACS, NOVAVIEW, NOVACARDIO, NOVAQC AND NOVAER	Aug 21, 2006	Substantially Equivalent	NOVARAD CORP.
K062107	SECURVIEW DX DIAGNOSTIC WORKSTATION, MODELS SV-0001, SV-0002 AND SV-0003	Aug 18, 2006	Substantially Equivalent	HOLOGIC, INC.
K061926	CORONIS 2MP AND MDCG 2121 - CB	Aug 18, 2006	Substantially Equivalent	BARCOVIEW
K062154	VITAL CONNECT 4.0	Aug 10, 2006	Substantially Equivalent	VITAL IMAGES, INC.
K061855	NEUROQUANT	Aug 10, 2006	Substantially Equivalent	CORTECHS LABS, INC
K062053	MONOCHROME LCD MONITOR, RADIFORCE, GS320	Aug 07, 2006	Substantially Equivalent	EIZO NANAO CORPORATION
K061964	SYNGO MULTIMODALITY WORKPLACE	Jul 27, 2006	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K061947	21.3 INCH MONOCHROME LCD MONITOR	Jul 25, 2006	Substantially Equivalent	NEC DISPLAY SOLUTIONS, LTD.
K061421	ERAD PACS	Jul 25, 2006	Substantially Equivalent	ERAD, INC.
K061447	5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)	Jul 21, 2006	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K061418	QUANTIVA	Jul 21, 2006	Substantially Equivalent	TOMOGRAPHIX IP LTD.
K061672	SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS	Jun 29, 2006	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS USA, INC.
K061671	SYNGO TRUED, MODEL VC10A	Jun 29, 2006	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS
K061624	VITREA, VERSION 3.9	Jun 27, 2006	Substantially Equivalent	VITAL IMAGES, INC.
K061472	GALILEOS IMPLANT, V 1.0	Jun 09, 2006	Substantially Equivalent	SICAT GMBH & CO. KG
K061160	M-VU CAD STATION	Jun 09, 2006	Substantially Equivalent	VUCOMP, INC.
K061061	20.1-INCH (51CM) COLOR LCD MONITOR CDL2009A (CCL204)	Jun 07, 2006	Substantially Equivalent	TOKOTU ELECTRIC CO., LTD.
K061035	TIGERVIEW PROFESSIONAL	Jun 05, 2006	Substantially Equivalent	TELEVERE SYSTEMS
K061396	QLAB QUANTIFICATION SOFTWARE	May 30, 2006	Substantially Equivalent	PHILIPS ULTRASOUND, INC.
K061372	CENTRICITY AW SUITE OPTION	May 30, 2006	Substantially Equivalent	GE HEALTHCARE INFORMATION TECHNOLOGIES
K061326	VOXAR 3D ENTERPRISE WITH CARDIAMETRIX	May 25, 2006	Substantially Equivalent	BARCOVIEW MIS EDINBURGH
K061305	MEDICAL DISPLAY, MDC1900-1LG (1LR)	May 25, 2006	Substantially Equivalent	CHILIN TECHNOLOGY CO. LTD
K061303	MEDICAL DISPLAY, MODELS MDM 1900-1NG AND MDM 1900-1NR	May 25, 2006	Substantially Equivalent	CHILIN TECHNOLOGY CO. LTD
K060950	3MATIC	May 18, 2006	Substantially Equivalent	MATERIALISE N.V.
K060816	MIM 4.0 (NEURO	May 16, 2006	Substantially Equivalent	MIMVISTA CORP.
K061214	AQUARIUSAPS SERVER	May 15, 2006	Substantially Equivalent	TERARECON, INC.
K061126	ACCUREX	May 09, 2006	Substantially Equivalent	CYBERMED, INC.
K061029	JETSTREAM WORKSPACE	May 01, 2006	Substantially Equivalent	ADAC LABORATORIES
K060961	15-INCH (38CM) COLOR LCD MONITOR CDL1566A	May 01, 2006	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K061018	PLANAR DOME EX LINE MODEL DOME E2C	Apr 28, 2006	Substantially Equivalent	PLANAR SYSTEMS, INC.
K060992	SYNGO US WORKPLACE	Apr 28, 2006	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS
K060845	MONOCHROME LCD MONITOR, RADIFORCE MODEL GS310	Apr 25, 2006	Substantially Equivalent	EIZO NANAO CORPORATION
K060941	CAAS MRV VERSION 3.0	Apr 19, 2006	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K060840	SVIEW	Apr 07, 2006	Substantially Equivalent	MRI CARDIAC SERVICES, INCORPORATED
K052424	MAXILIM	Mar 31, 2006	Substantially Equivalent	MEDICIM NV
K060505	VOXAR 3D ENTERPRISE, MODEL 6.1	Mar 29, 2006	Substantially Equivalent	BARCOVIEW MIS EDINBURGH
K060451	M-VU VIEWER STATION	Mar 22, 2006	Substantially Equivalent	VUCOMP, INC.
K060267	VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE	Mar 17, 2006	Substantially Equivalent	IMPLANT LOGIC SYSTEMS, LTD.
K060263	IQPACS	Mar 15, 2006	Substantially Equivalent	S.C. INFO WORLD S.R.L.
K060453	AZE VIRTUALPLACE	Mar 09, 2006	Substantially Equivalent	AZE, LTD.
K060378	VITREA2 VERSION 3.8.1	Mar 09, 2006	Substantially Equivalent	VITAL IMAGES, INC.
K060035	MDXNET	Mar 09, 2006	Substantially Equivalent	CYBERMDX, INC.
K053039	CLINTON ELECTRONICS SERIES II DIGITAL GRAYSCALE MONITORS, MODELS DL2000, DL3000, DL2000 OF AND DL3000 OF	Mar 01, 2006	Substantially Equivalent	CLINTON ELECTRONICS CORP.
K053183	JIVE X SOFTWARE	Feb 16, 2006	Substantially Equivalent	VISUS TECHNOLOGY TRANSFER GMBH
K060210	MEDIPORT	Feb 10, 2006	Substantially Equivalent	MAXANT TECHNOLOGIES, INC.
K053592	SIMPLANT DR. JAMES	Feb 08, 2006	Substantially Equivalent	MATERIALISE N.V.
K060055	KODAK PACS	Feb 07, 2006	Substantially Equivalent	EASTMAN KODAK COMPANY
K053301	CEDARA I-RESPONSE CEDARA PET/CT	Feb 03, 2006	Substantially Equivalent	CEDARA SOFTWARE CORP.
K060136	PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR	Jan 31, 2006	Substantially Equivalent	PLANAR SYSTEMS, INC.
K053455	ENCOMPASS.NET	Jan 25, 2006	Substantially Equivalent	EMPIRIC SYSTEMS, LLC
K053347	KODAK CARESTREAM PACS	Jan 04, 2006	Substantially Equivalent	EASTMAN KODAK COMPANY
K052988	CAAS	Dec 30, 2005	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K052942	21.3INCH MONOCHROME LCD MONITOR	Dec 27, 2005	Substantially Equivalent	NEC-MITSUBISHI ELECTRIC VISUAL SYSTEMS CORP.
K053458	WEB1000	Dec 22, 2005	Substantially Equivalent	AGFA CORP.
K052467	BRAIN VIEWRX VIEWER, VERSION 1.0	Dec 20, 2005	Substantially Equivalent	KYRON CLINICAL IMAGING, INC.
K052120	LUMIMED MONOCHROME LCD MONITOR, MODELS MM 20, MM 30 AND MM50	Dec 16, 2005	Substantially Equivalent	HEEYOUNG CO., LTD.
K052632	VITREA2 VERSION 3.8 MEDICAL IMAGE PROCESSING SOFTWARE	Dec 15, 2005	Substantially Equivalent	VITAL IMAGES, INC.
K053162	DEXTROSCOPE & DEXTROBEAM	Dec 09, 2005	Substantially Equivalent	VOLUME INTERACTIONS PTE LTD
K053281	EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE)	Dec 07, 2005	Substantially Equivalent	EMAGEON INC.
K053133	SYNGO DYNAMICS, VERSION 5.0	Dec 05, 2005	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K052963	MEDIQ VERSION 1.0	Dec 05, 2005	Substantially Equivalent	CLARIO MEDICAL IMAGING, INC.
K053155	VIMPLANT	Nov 23, 2005	Substantially Equivalent	CYBERMED, INC.
K053010	VISTADENT AT COMPLETE, MODEL 3.1	Nov 22, 2005	Substantially Equivalent	DENTSPLY INTL., INC.
K053043	ENCOMPASS SOFTWARE PACKAGE	Nov 18, 2005	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K052618	IMAGECAST PACS	Nov 17, 2005	Substantially Equivalent	IDX SYSTEMS CORP.
K052958	COLOR NIO 2MP, E-2320 C	Nov 16, 2005	Substantially Equivalent	BARCOVIEW
K052537	CATELLA DIAGNOSTIC WORKSTATION, VERSION 4.0	Nov 16, 2005	Substantially Equivalent	AMERICAN MEDICAL SALES, INC.
K052995	ADVANTAGE WORKSTATION 4.3.	Nov 08, 2005	Substantially Equivalent	GE HEALTHCARE
K052545	INFINITT G3 PACS	Nov 08, 2005	Substantially Equivalent	INFINITT CO., LTD.
K052775	SYNGO MULTIMODALITY WORKPLACE (SYNGO MM WP)	Oct 31, 2005	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K052379	MIM 3.5 (CIRCA)	Oct 31, 2005	Substantially Equivalent	MIMVISTA CORP.
K052895	FOURSIGHT VIEWTOOL IMAGE VIEWER	Oct 27, 2005	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K052284	REFORMAT GATEWAY	Oct 17, 2005	Substantially Equivalent	INFINITT CO., LTD.
K052312	WIDE 5MP (MAMMO) LCD MONITOR SYSTEM	Oct 07, 2005	Substantially Equivalent	WIDE CORPORATION
K052358	ETIAM STAR PACS COMPONENTS	Oct 05, 2005	Substantially Equivalent	ETIAM, S.A.
K052529	E-2320 PA S	Sep 30, 2005	Substantially Equivalent	BARCOVIEW
K052352	COLOR CORONIS 2MP-21 AND MFCD 2321	Sep 30, 2005	Substantially Equivalent	BARCOVIEW
K052478	MFCD 1219, MFCD 1219 TS	Sep 28, 2005	Substantially Equivalent	BARCOVIEW
K052461	SYNGO IMAGING VERSION V20A	Sep 22, 2005	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K052199	21.3-INCH(54 CM) MONOCHROME LCD MONITOR MDL2115A (ME353I), (DV3MM-HB), (ME353IM)	Sep 22, 2005	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K052460	POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE	Sep 21, 2005	Substantially Equivalent	RAMSOFT, INC.
K052411	HIPAX MEDICAL IMAGING SOFTWARE	Sep 21, 2005	Substantially Equivalent	STEINHART MEDIZINSYSTEME GMBH
K052276	NIO 2MP-20 AND E-2620 S	Sep 21, 2005	Substantially Equivalent	BARCOVIEW
K052429	CORONIS 3MP-21 AND MFGD 3621	Sep 15, 2005	Substantially Equivalent	BARCOVIEW
K052403	CORONIS 2MP-21 AND MFGD 2621	Sep 15, 2005	Substantially Equivalent	BARCOVIEW
K052344	COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C	Sep 14, 2005	Substantially Equivalent	EIZO NANAO CORPORATION
K052337	MONOCHROME LCD MONITOR, MODEL RADIFORCE G33	Sep 08, 2005	Substantially Equivalent	EIZO NANAO CORPORATION
K052159	AIDA COMPACT II SYSTEM	Sep 07, 2005	Substantially Equivalent	KARL STORZ ENDOSCOPY-AMERICA, INC.
K051853	CARDIOSTREAM SONOAIM	Aug 22, 2005	Substantially Equivalent	CARDIOSTREAM, LLC
K051901	NIO 3MP-21	Aug 17, 2005	Substantially Equivalent	BARCOVIEW
K051840	ENSITE VERISMO SOFTWARE	Aug 15, 2005	Substantially Equivalent	ST. JUDE MEDICAL
K051813	ULTRAPACS	Aug 15, 2005	Substantially Equivalent	ULTRARAD CORPORATION
K051809	EASYVIZ, EASYVIZ SYSTEM, EASYVIZ PACS SYSTEM, EASYVIZ IMAGE AND DATA MANAGEMENT SYSTEM	Aug 15, 2005	Substantially Equivalent	MEDICAL INSIGHT A/S
K051902	NIO 2MP-21	Aug 11, 2005	Substantially Equivalent	BARCOVIEW
K051586	VIEWSEND MEDICAL SYSTEM	Aug 04, 2005	Substantially Equivalent	KENEI CO., LTD.
K051715	STARPACS DENTAL	Aug 02, 2005	Substantially Equivalent	INFINITT CO., LTD.
K051649	VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0	Aug 02, 2005	Substantially Equivalent	CAMTRONICS MEDICAL SYSTEMS
K051639	AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM	Aug 02, 2005	Substantially Equivalent	AS SOFTWARE, INC.
K051743	R2 BREAST IMAGING WORKSTATION	Jul 25, 2005	Substantially Equivalent	R2 TECHNOLOGY, INC.
K050862	3TP WORKSPACE	Jul 25, 2005	Substantially Equivalent	3TP LLC
K051528	MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE	Jul 20, 2005	Substantially Equivalent	MEVIS TECHNOLOGY GMBH & CO. KG
K051523	REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION	Jul 20, 2005	Substantially Equivalent	KONICA MINOLTA MEDICAL & GRAPHIC, INC.
K051673	XELERIS 2 PROCESSING AND REVIEW WORKSTATION	Jul 18, 2005	Substantially Equivalent	GE MEDICAL SYSTEMS
K051745	ECHOSYSTEM	Jul 14, 2005	Substantially Equivalent	MEDSTRAT, INC.
K051403	19-INCH (48CM) COLOR LCD MONITOR CDL1904A	Jul 14, 2005	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD.
K051553	FUJI SYNAPSE WORKSTATION SOFTWARE	Jul 07, 2005	Substantially Equivalent	FUJIFILM MEDICAL SYSTEMS USA, INC.
K051392	BTI-SCAN, VERSION 4.0	Jun 29, 2005	Substantially Equivalent	B.T.I. BIOTECHNOLOGY INSTITUTE, S.L.
K051521	REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION	Jun 28, 2005	Substantially Equivalent	KONICA MINOLTA MEDICAL & GRAPHIC, INC.
K051037	IMAGEQUBE PACS	Jun 28, 2005	Substantially Equivalent	INTUITIVE IMAGING INFORMATICS, LLC
K051331	19-INCH (48 CM) COLOR LCD MONITOR CDL1902A	Jun 27, 2005	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K051325	WEBPAX, MODEL 200	Jun 15, 2005	Substantially Equivalent	HEART IMAGING TECHNOLOGIES, LLC
K051315	MODIFICATION TO: SECTRA IDS5 WORKSTATION	Jun 15, 2005	Substantially Equivalent	SECTRA IMTEC AB
K051127	KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0	Jun 03, 2005	Substantially Equivalent	KIKA MEDICAL INC.
K051201	E1 MEDICAL FLAT PANEL DISPLAY SYSTEM AND MFGD 1218 MEDICAL FLAT PANEL DISPLAY	May 26, 2005	Substantially Equivalent	BARCOVIEW
K050993	MMS VIDEO OPTION	May 26, 2005	Substantially Equivalent	MEDICAL MEASUREMENT SYSTEMS,B.V.
K050846	B-CAD SYSTEM, VERSION 1.0	May 26, 2005	Substantially Equivalent	THE MEDIPATTERN CORPORATION
K050943	GE VIEWPOINT	May 23, 2005	Substantially Equivalent	GENERAL ELECTRIC CO.
K051081	ESSENPACS	May 12, 2005	Substantially Equivalent	CYMED ENGINEERING, INC.
K050736	IMORGON ULTRASOUND PACS SOLUTIONS	May 05, 2005	Substantially Equivalent	SEA RIDGE SOFTWARE, INC.
K050619	20.8-INCH (53CM) COLOR LCD MONITOR, MODELS CDL2112A, CCL350I & DV3MC-HB	Apr 26, 2005	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K050617	21.3-INCH (54CM) MONOCHROME LCD MONITOR, MODELS MDL2109A, ME251I & DV2MM-HB	Apr 22, 2005	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K050751	IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X	Apr 21, 2005	Substantially Equivalent	AGFA CORP.
K050744	KAVO ERGOCOM/ERGOCAM	Apr 21, 2005	Substantially Equivalent	KAVO AMERICA CORPORATION
K050703	QBRAIN	Apr 21, 2005	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K050616	21.3-INCH (54CM) COLOR LCD MONITOR, MODELS CDL2113A, CCL250I & DV2MC-HB	Apr 21, 2005	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K050485	20.8-INCH(53CM) MONOCHROME LCD MONITOR MDL2110A (ME351I), (DV3MM-HB)	Apr 07, 2005	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K050376	PROWIN	Apr 07, 2005	Substantially Equivalent	MEDICAL TECHNOLOGIES INTERNATIONAL, INC.
K050667	R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE	Mar 29, 2005	Substantially Equivalent	R2 TECHNOLOGY, INC.
K050341	IMPLANT LOCATION SOFTWARE, MODEL 0.1.0	Mar 29, 2005	Substantially Equivalent	TACTILE TECHNOLOGIES, LTD.
K050298	IPACS PRISM-5.0	Feb 28, 2005	Substantially Equivalent	REALTIMEIMAGE INC.
K050196	SECTRA IDS5 WORKSTATION	Feb 24, 2005	Substantially Equivalent	SECTRA IMTEC AB
K050228	AGFA HEARTLAB CARDIOVASCULAR	Feb 18, 2005	Substantially Equivalent	HEARTLAB, INC.
K050033	LUCION	Feb 11, 2005	Substantially Equivalent	MEVISYS CO. LTD
K042755	MONOCHROME LCD MONITOR, RADIFORCE G51	Feb 10, 2005	Substantially Equivalent	EIZO NANAO CORPORATION
K043122	SMD 21500 OR DSB-2103-D-5MP-5M PIXEL GRAYSCALE FLAT PANEL DISPLAY	Feb 09, 2005	Substantially Equivalent	SIEMENS AG
K043483	RADIN, MODEL V 3.0	Jan 28, 2005	Substantially Equivalent	SOHARD AG
K043430	20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB	Jan 28, 2005	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K043415	CENTRICITY PACS SYSTEM	Jan 21, 2005	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K043194	VOXAR 3D PRODUCT FAMILY	Jan 11, 2005	Substantially Equivalent	VOXAR LIMITED
K043216	CADSTREAM VERSION 4.0	Jan 06, 2005	Substantially Equivalent	CONFIRMA, INC.
K042868	MAMMOREPORT SOFTCOPY WORKSTATION	Jan 06, 2005	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K043360	IMT.LAB	Jan 05, 2005	Substantially Equivalent	PIE MEDICAL
K043146	HORIZON MEDICAL IMAGING	Jan 04, 2005	Substantially Equivalent	MCKESSON MEDICAL IMAGING COMPANY
K042221	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	Dec 30, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K041078	SURGPLAN AND PANPLAN	Dec 23, 2004	Substantially Equivalent	IMAGING SCIENCES INTL., INC.
K043412	MODIFICATION TO: VIEWSTATION	Dec 20, 2004	Substantially Equivalent	IMPAC MEDICAL SYSTEMS, INC.
K043350	MISTAR, MODEL V3.2	Dec 15, 2004	Substantially Equivalent	APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD.
K043333	VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM	Dec 15, 2004	Substantially Equivalent	VITAL IMAGES, INC.
K043134	METRX WORKSTATION	Dec 13, 2004	Substantially Equivalent	MEDICAL METRX SOLUTIONS, INC.
K042995	X-LEONARDO	Nov 24, 2004	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K042353	AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS	Nov 24, 2004	Substantially Equivalent	NATIONAL DISPLAY SYSTEMS
K042942	MGP 15 DICOM THEATER	Nov 22, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K042662	NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	Nov 22, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K043097	3VISEON	Nov 19, 2004	Substantially Equivalent	3MENSIO MEDICAL IMAGING BV
K042697	SECOND LOOK VIEWER	Nov 19, 2004	Substantially Equivalent	ICAD INC.
K042661	NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM	Nov 19, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K042660	NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM	Nov 19, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K042816	TRAUMACAD 1.2	Nov 10, 2004	Substantially Equivalent	ORTHOCRAT, LTD.
K042700	IMAGE MEDICAL ACQUISITION STATION (IMAS)	Nov 08, 2004	Substantially Equivalent	ERAD IMAGEMEDICAL CORP.
K042867	PHILIPS ORTHOPAEDIC APPLICATIONS	Nov 02, 2004	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K042832	SIENET COSMOS (VERSION V15A)	Oct 28, 2004	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K042212	IMPLANTMASTER	Oct 21, 2004	Substantially Equivalent	I-DENT
K042383	RSA-CMS	Oct 20, 2004	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K042781	IPACS CARDIO	Oct 19, 2004	Substantially Equivalent	REAL TIME IMAGE INC.
K042634	WIDE 1MP LCD MONITOR SYSTEM	Oct 08, 2004	Substantially Equivalent	WIDE CORPORATION
K042692	CLARITY FUSION	Oct 07, 2004	Substantially Equivalent	SHARED P.E.T. IMAGING, LLC
K042647	EXAM-PACS	Oct 07, 2004	Substantially Equivalent	COACTIV, LLC
K042525	CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION	Oct 01, 2004	Substantially Equivalent	GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES
K042507	UBIPACS	Sep 27, 2004	Substantially Equivalent	ICM CO., LTD.
K042334	ALLURA 3D-CA, RELEASE 1	Sep 27, 2004	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K042203	LEONARDO SYNGO CARDIOLOGY WORKSTATION	Sep 24, 2004	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K042042	ULTRASOUND CAPTURE SYSTEM	Sep 21, 2004	Substantially Equivalent	HEARTLAB, INC.
K042313	INTEGRADWEB MPR/MIP	Sep 09, 2004	Substantially Equivalent	DYNAMIC IMAGING INC.
K042311	PACSPARTNER	Sep 09, 2004	Substantially Equivalent	MEDICAL STANDARD CO., LTD.
K042292	ISITE PACS	Sep 08, 2004	Substantially Equivalent	STENTOR, INC.
K042008	ULTRAVISUAL	Sep 03, 2004	Substantially Equivalent	EMAGEON UV, INC.
K041508	BARCOVIEW CORONIS 5MP HD MEDICAL FLAT PANEL DISPLAY SYSTEM	Aug 27, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K041935	DR SYSTEMS PACS, RELEASE 6.1	Aug 16, 2004	Substantially Equivalent	DR. SYSTEMS, INC.
K041782	SEEMOR 5.0 IMAGE DISPLAY PROGRAM	Aug 16, 2004	Substantially Equivalent	AREEDA ASSOC., LTD.
K041555	SECURVIEW DX SOFTCOPY WORKSTATION	Aug 09, 2004	Substantially Equivalent	HOLOGIC, INC.
K041990	FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP	Aug 06, 2004	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K041484	UNDECIDED	Jul 30, 2004	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K040686	M'ATH STD	Jul 30, 2004	Substantially Equivalent	INTELLIGENCE IN MEDICAL TECHNOLOGIES
K041682	CAAS MRV	Jul 27, 2004	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K041326	MEDCOMMONS OPEN RADIOLOGY GATEWAY	Jul 27, 2004	Substantially Equivalent	MEDCOMMONS, INC.
K041162	ORTHO-CMS	Jul 27, 2004	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K040931	PATXFER RT	Jul 22, 2004	Substantially Equivalent	BRAINLAB, AG
K040896	MODIFICATION TO ENCOMPASS	Jul 16, 2004	Substantially Equivalent	HEARTLAB, INC.
K041761	RAPIDIACOLON	Jul 13, 2004	Substantially Equivalent	INFINITT CO., LTD.
K041737	5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR ME511L (MDL2105A)	Jul 13, 2004	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K041029	KINETDX	Jul 08, 2004	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS, INC.
K040970	LEONARDO	Jul 08, 2004	Substantially Equivalent	SIEMENS MEDICAL SYSTEMS, INC.
K041597	MONOCHROME LCD MONITOR, MODEL RADIFORCE G22	Jun 24, 2004	Substantially Equivalent	EIZO NANAO CORPORATION
K041581	COMPACS, VERSION 1.0	Jun 22, 2004	Substantially Equivalent	INTELLIGENT IMAGES SRL
K041500	STARPACS ORTHOPEDICS SYSTEM	Jun 21, 2004	Substantially Equivalent	INFINITT CO., LTD.
K040310	NOVA FAMILY OF MEDICAL RADIOLOGY DISPLAYS	Jun 17, 2004	Substantially Equivalent	NATIONAL DISPLAY SYSTEMS
K040443	DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I	Jun 16, 2004	Substantially Equivalent	DOME IMAGING SYSTEMS, INC.
K040697	21.3-INCH (54CM) COLOR LCD MONITOR CCL212 (CDL2107A)	Jun 10, 2004	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K041366	IPACS ORTHO	Jun 08, 2004	Substantially Equivalent	REAL TIME IMAGE INC.
K040746	MRA-CMS	Jun 08, 2004	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K040695	21,3-INCH (54CM) MONOCHROME LCD MONITOR ME213L (MDL2108A)	Jun 07, 2004	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K033859	BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY	Jun 02, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K041270	CT COLONOGRAPHY II	May 27, 2004	Substantially Equivalent	GENERAL ELECTRIC MEDICAL SYSTEMS
K040555	IMPAX CLIENT EMBRACE	May 26, 2004	Substantially Equivalent	AGFA CORP.
K033849	SIMPLANT SYSTEM	May 25, 2004	Substantially Equivalent	MATERIALISE N.V.
K040982	COLOR LCD MONITOR, MODEL RADIFORCE R12	May 13, 2004	Substantially Equivalent	EIZO NANAO CORPORATION
K040344	IMPAX OT3000 ORTHOPEDIC WORKSTATION	May 12, 2004	Substantially Equivalent	AGFA CORP.
K033912	CRADLE PACS	May 11, 2004	Substantially Equivalent	CRADLE TECHNOLOGY CORP.
K040376	SECTRA IDS5 RADIOLOGY WORKSTATION; SECTRA MPR PACKAGE; SECTRA 3D PACKAGE	May 04, 2004	Substantially Equivalent	SECTRA-IMTEC AB
K040365	COLOR CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM	Apr 28, 2004	Substantially Equivalent	BARCO NV
K040546	IMAGE-ARENA AND RESEARCH-ARENA APPLICATIONS	Apr 27, 2004	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K040852	PREVIEW TREATMENT PLANNING SOFTWARE	Apr 23, 2004	Substantially Equivalent	MEDICAL MEDIA SYSTEMS, INC.
K040468	CEDARA I-SOFTVIEW AND CEDARA I-READMAMMO	Apr 23, 2004	Substantially Equivalent	CEDARA SOFTWARE CORP.
K033153	DICOM THEATER	Apr 23, 2004	Substantially Equivalent	FERGUSON MEDICAL
K031661	5M MEDICAL FLAT PANEL DISPLAY, ME511L	Apr 23, 2004	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K033006	MIVD 1218 18 INCH GREYSCALE LCD DISPLAY MODULE	Apr 20, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K040876	ICONNECTION, VERSION 3.2.0.0 MEDICAL IMAGE PROCESSING SOFTWARE	Apr 19, 2004	Substantially Equivalent	VITAL IMAGES, INC.
K040126	VIATRONIX V3D COLON, REVISION 1.3	Apr 19, 2004	Substantially Equivalent	VIATRONIX, INC.
K033104	MGD 2621P MEDICAL GREYSCALE DISPLAY	Apr 19, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K033005	MFGD 1318 18 INCH 1 MEGAPIXEL GREYSCALE LCD DISPLAY	Apr 19, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K033103	MGD 2621L MEDICAL GREYSCALE DISPLAY	Apr 16, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K033004	MFGD 2320 20 INCH 2 MEGAPIXEL GREYSCALE LCD DISPLAY	Apr 16, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K040158	MFCD 2320	Apr 12, 2004	Substantially Equivalent	BARCO NV
K040195	CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM	Apr 07, 2004	Substantially Equivalent	WITT BIOMEDICAL CORP
K040399	QONTRAST	Mar 29, 2004	Substantially Equivalent	AMID
K040041	NIO 3MP MEDICAL GRAYSCALE DISPLAY SYSTEM	Mar 29, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K040040	NIO 5MP MEDICAL GRAYSCALE DISPLAY SYSTEM	Mar 29, 2004	Substantially Equivalent	BARCO NV BARCOVIEW
K040050	INSTATRAK SYSTEM WITH MULTIPLE DATASET NAVIGATION, MODEL IT3500	Mar 24, 2004	Substantially Equivalent	GE MEDICAL SYSTEMS NAVIGATION AND VISUALIZATION IN
K040039	NIO 2MP MEDICAL GRAYSCALE DISPLAY SYSTEM	Mar 17, 2004	Substantially Equivalent	BARCO NV
K033955	RTIST	Mar 17, 2004	Substantially Equivalent	MIRADA SOLUTIONS LTD.
K033920	CAAS II RVA	Mar 17, 2004	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K040486	MEDIPACS	Mar 11, 2004	Substantially Equivalent	NEOBIT CO., LTD.
K034059	SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE	Mar 09, 2004	Substantially Equivalent	SECTRA AB
K032555	3M COLOR MEDICAL FLAT PANEL DISPLAY, CCL316	Feb 26, 2004	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K040305	VITREA2 VERSION 3.5	Feb 24, 2004	Substantially Equivalent	VITAL IMAGES, INC.
K033466	COLOR LCD DISPLAY, MODEL RADIFORCE R22	Feb 20, 2004	Substantially Equivalent	EIZO NANAO CORPORATION
K040254	INTEGRIS 3D-RA, RELEASE 4.2	Feb 19, 2004	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K040227	QLAB QUANTIFICATION SOFTWARE	Feb 17, 2004	Substantially Equivalent	PHILIPS ULTRASOUND
K040142	ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE	Feb 06, 2004	Substantially Equivalent	ADAC LABORATORIES
K033825	ORTHOPACS	Feb 02, 2004	Substantially Equivalent	ETRAUMA.COM CORP.
K032531	CHASE CARDIAC ANALYSIS SYSTEM	Feb 02, 2004	Substantially Equivalent	CHASE MEDICAL, INC.
K040028	CA-1500	Jan 22, 2004	Substantially Equivalent	R2 TECHNOLOGY, INC.
K033712	MODIFICATION TO SECTRA IDS5 RADIOLOGY WORKSTATION - VERSION 10.1	Dec 23, 2003	Substantially Equivalent	SECTRA-IMTEC AB
K033831	SIENET COSMOS	Dec 19, 2003	Substantially Equivalent	SIEMENS AG, MEDICAL SOLUTIONS
K033624	PACS SOFTWARE SOLUTION 2003	Dec 15, 2003	Substantially Equivalent	CANON U.S.A., INC.
K033400	SENO ADVANTAGE	Dec 04, 2003	Substantially Equivalent	GE MEDICAL SYSTEMS W-400
K031132	CONSULTIVA CASE INPUT STATION, MODEL CIS-1	Nov 26, 2003	Substantially Equivalent	EASTMAN KODAK COMPANY
K033013	MDIFICATION TO MEDIPRIME	Nov 25, 2003	Substantially Equivalent	ALGOTEC SYSTEMS, LTD.
K033361	VIATRONIX V3D VASCULAR, REVISION 1.0	Nov 05, 2003	Substantially Equivalent	VIATRONIX, INC.
K033093	ECHOCONNEX COMMUNICATOR	Nov 05, 2003	Substantially Equivalent	CONNEXMD
K031473	RATIONAL IMAGING PACS	Oct 30, 2003	Substantially Equivalent	INTUITIVE IMAGING INFORMATICS, LLC
K033088	SECTRA IDS5 RADIOLOGY WORKSTATION VERSION 10.1	Oct 29, 2003	Substantially Equivalent	SECTRA AB
K032748	VITREA2, VERSION 3.4 MEDICAL IMAGE PROCESSING SOFTWARE	Oct 29, 2003	Substantially Equivalent	VITAL IMAGES, INC.
K032546	HOLOGIC DR IMAGEPRO	Oct 16, 2003	Substantially Equivalent	HOLOGIC, INC.
K032533	INTELEPACS	Oct 16, 2003	Substantially Equivalent	INTELERAD MEDICAL SYSTEMS INC.
K032186	AUTOALIGN	Oct 14, 2003	Substantially Equivalent	CORTECHS LABS, INC.
K032924	RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3	Oct 10, 2003	Substantially Equivalent	VOLUME INTERACTIONS PTE LTD
K032960	WIDE 2MP TFT LCD MONITOR SYSTEM IF 1902A	Oct 08, 2003	Substantially Equivalent	WIDE CORPORATION
K032324	ECHOENCODER	Oct 02, 2003	Substantially Equivalent	ICARDIOGRAM, INCORPORATED
K031590	SECTRA ORTHOPEDIC PACKAGE	Oct 02, 2003	Substantially Equivalent	SECTRA-IMTEC AB
K031567	3D INVIVO BY CSIST	Oct 02, 2003	Substantially Equivalent	CHUNG-SHAN INSTITUTE OF SCIENCE AND TECHNOLOGY
K032176	RATTAN IMACS BY RATTAN INFORMATION CORPORATION	Sep 25, 2003	Substantially Equivalent	RATTAN INFORMATION CORPORATION
K032157	TELEMIS-MEDICAL SOLUTION	Sep 24, 2003	Substantially Equivalent	TELEMIS S.A.
K032760	APAX PACS SYSTEM	Sep 17, 2003	Substantially Equivalent	TIS, INC.
K032638	DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY	Sep 11, 2003	Substantially Equivalent	PLANAR SYSTEMS, INC.
K032020	51CM(20.1INCH) TFT MONOCHROME LCD MONITOR, MU5111BW	Sep 02, 2003	Substantially Equivalent	IIYAMA CORPORATION
K032026	LCD MONITOR, RADIFORCE G11, G31, G51	Aug 27, 2003	Substantially Equivalent	EIZO NANAO CORPORATION
K032483	VIATRONIX V3D EXPLORER, REVISION 1.2	Aug 22, 2003	Substantially Equivalent	VIATRONIX, INC.
K032401	ORTHOVIEW	Aug 14, 2003	Substantially Equivalent	OMSBAR LTD
K031836	PHILIPS FRESCO RELEASE 1	Aug 14, 2003	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K031816	DVNET MDV-PACS	Aug 14, 2003	Substantially Equivalent	DVNET INTERNATIONAL TECHNOLOGY CO.,LTD.
K031562	RAMSOFT PACS, MODEL 3.0	Aug 11, 2003	Substantially Equivalent	RAMSOFT, INC.
K031778	PRACTICEBUILDER 1-2-3	Aug 07, 2003	Substantially Equivalent	ERAD IMAGEMEDICAL CORP.
K031779	CADSTREAM	Aug 06, 2003	Substantially Equivalent	CONFIRMA, INC.
K032202	DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODELS C2 AND C5I	Aug 01, 2003	Substantially Equivalent	PLANAR SYSTEMS, INC.
K031704	FILMLESS CLINIC	Jul 31, 2003	Substantially Equivalent	CONNECT IMAGING, INC.
K032174	WIDE 3MP GRAYSCALE TFT LCD MONITOR IF2103A	Jul 24, 2003	Substantially Equivalent	WIDE CORPORATION
K031638	CARDIO VASCULAR INFORMATION ENHANCED WORKSTATION	Jul 21, 2003	Substantially Equivalent	ELECTROMED IMAGING INC.
K032096	PHILIPS VIEWFORUM 2003	Jul 18, 2003	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K031929	5MP TFT LCD MONITOR SYSTEM IF2105A BY WIDE CORPORATION	Jul 08, 2003	Substantially Equivalent	WIDE CORPORATION
K031372	PERSONAL DIGITAL WORKSTATION (PDW); FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION	Jul 02, 2003	Substantially Equivalent	MAXXVISION, LLC
K031886	SONOVIEW PRO BY MEDISON CO., LTD.	Jun 30, 2003	Substantially Equivalent	MEDISON CO., LTD.
K031311	INTEGRADWEB BY DYNAMIC IMAGING, INC.	Jun 20, 2003	Substantially Equivalent	DYNAMIC IMAGING INC.
K031248	CONSULTIVA REPORT STATION, MODEL RS-1	Jun 20, 2003	Substantially Equivalent	MIRAMEDICA, INC
K030781	KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB	May 29, 2003	Substantially Equivalent	EASTMAN KODAK COMPANY
K030751	IPACS PRISM	May 29, 2003	Substantially Equivalent	REAL TIME IMAGE INC.
K030728	FYRELINK VL	May 23, 2003	Substantially Equivalent	MPACS, LLC.
K030347	20.1 MONOCHROME LCD MONITOR, RADIFORCE G20	May 02, 2003	Substantially Equivalent	EIZO NANAO CORPORATION
K030276	FLAT PANEL DISPLAYS, CDL SERIES	Apr 25, 2003	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K030274	MEDICAL FLAT PANEL DISPLAY, ME315L	Apr 25, 2003	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K030272	FLAT PANEL DISPLAY, ME183L	Apr 25, 2003	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K031013	INFINTT CO., LTD. STARPACS SYSTEM	Apr 17, 2003	Substantially Equivalent	INFINITT COMPANY
K030982	SYNGO COLONOGRAPHY SOFTWARE PACKAGE	Apr 08, 2003	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K030457	REX, VERSION 3.0	Apr 08, 2003	Substantially Equivalent	POINTDX, INC
K030635	THE OBSIDIAN PACS SYSTEM	Mar 28, 2003	Substantially Equivalent	OBSIDIAN MEDICAL TECHNOLOGY, INC.
K030363	ORG@NIZER, MODEL VERSION 3.0	Mar 27, 2003	Substantially Equivalent	EBIT SANITA, S.P.A.
K024358	20.1 MONOCHROME LCD MONITOR, RADIFORCE G21	Mar 25, 2003	Substantially Equivalent	EIZO NANAO CORPORATION
K030242	FYRELINK	Mar 10, 2003	Substantially Equivalent	MPACS, LLC.
K024159	STRYKERWARE SYSTEM	Mar 10, 2003	Substantially Equivalent	Stryker Endoscopy
K030223	SONOCALC	Feb 06, 2003	Substantially Equivalent	SONOMETRIC HEALTH, LLC
K022877	OBSERVER ULTRASOUND REPORTING AND IMAGING SYSTEM	Feb 05, 2003	Substantially Equivalent	VISION CHIPS, INC.
K024103	IVUS PLUS	Jan 24, 2003	Substantially Equivalent	INDEC SYSTEMS, INC.
K024028	SHARP VIEW IMAGE ENHANCEMENT SYSTEM	Jan 24, 2003	Substantially Equivalent	CONTEXT VISION AB
K023533	BARCO MEDIS 5MP2 AURA	Jan 17, 2003	Substantially Equivalent	BARCO NV
K024137	JUPITER PROCESSING AND REVIEW WORKSTATION	Jan 15, 2003	Substantially Equivalent	GE MEDICAL SYSTEMS, INC.
K023460	PACSPLUS	Jan 09, 2003	Substantially Equivalent	MEDICAL STANDARD CO., LTD.
K023476	UNIPACS WORKSTATION	Jan 07, 2003	Substantially Equivalent	UNIVERSAL PACS, INC.
K023467	HCP DICOM NET	Jan 07, 2003	Substantially Equivalent	SOFTLINK INTERNATIONAL INC.
K023394	UNISIGHT SYSTEM WITH UNIGATE	Jan 07, 2003	Substantially Equivalent	ELECTRONIC BUSINESS MACHINE CO., LTD. (EBM)
K023877	Q LAB QUANTIFICATION SOFTWARE WITH STRAIN RATE QUANTIFICATION PLUG-IN	Dec 23, 2002	Substantially Equivalent	PHILIPS ULTRASOUND, INC.
K023341	CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	Dec 23, 2002	Substantially Equivalent	BARCO NV
K023340	CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM	Dec 23, 2002	Substantially Equivalent	BARCO NV
K023339	IMAGETILE	Dec 23, 2002	Substantially Equivalent	BARCO NV
K023322	CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM	Dec 23, 2002	Substantially Equivalent	BARCO NV
K023246	AMALGA PACS	Dec 23, 2002	Substantially Equivalent	GLOBAL CARE SOLUTIONS, S.A.
K023936	MODIFICATION TO MEDIPRIME	Dec 20, 2002	Substantially Equivalent	ALGOTEC SYSTEMS, LTD.
K023137	PHILIPS EASYVISION WORKSTATION RELEASE 6	Dec 19, 2002	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K022773	BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM	Dec 13, 2002	Substantially Equivalent	BARCO NV
K023772	KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM	Nov 22, 2002	Substantially Equivalent	ACUSON CORP.
K022970	AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0	Nov 22, 2002	Substantially Equivalent	AMICAS, INC.
K023003	IMAGECHECKER-CT WORKSTATION	Nov 20, 2002	Substantially Equivalent	R2 TECHNOLOGY, INC.
K023557	CENTRICITY PACS PLUS	Nov 07, 2002	Substantially Equivalent	GE MEDICAL SYSTEMS
K023440	PHILIPS DIGITAL IMAGING OPTION RELEASE 1	Oct 30, 2002	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K022938	VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3	Oct 25, 2002	Substantially Equivalent	VOLUME INTERACTIONS PTE LTD
K022788	PHILIPS HARMONY RELEASE 1	Oct 25, 2002	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K023190	E.CAM COMPUTER / E.SOFT WORKSTATION	Oct 24, 2002	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K022881	CEDARA I-SOFTVIEW	Oct 22, 2002	Substantially Equivalent	CEDARA SOFTWARE CORP.
K022824	ECHO-VIEW 5.X, EASY-VIEW 2.X, OMNI VIEW 2.X, CARDIO-VIEW 1.X, LV ANALYSIS 1.X & SURGICAL VIEW 1.X	Oct 17, 2002	Substantially Equivalent	TOMTEC IMAGING SYSTEMS, GMBH
K023100	ACCUSKETCH CARDIAC QUANTITATIVE SYSTEM W/ ADVANCED ANALYSIS COMPONENTS	Oct 11, 2002	Substantially Equivalent	GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN
K022940	IN-VISION VIEW WITH MEASUREMENTS MODULE, MODEL 1.0	Oct 11, 2002	Substantially Equivalent	INTELLIGENT IMAGES SRL
K022710	SMARTPACS	Oct 11, 2002	Substantially Equivalent	TAIWAN ELECTRONIC DATA PROCESSING CORPORATION
K022692	VOXELPLUS PACS	Oct 11, 2002	Substantially Equivalent	MEVISYS CO. LTD
K022585	KIMAX QMA	Oct 11, 2002	Substantially Equivalent	MEDICAL METRICS, INC.
K022896	CSV12 SOFTWARE VIEWER	Oct 03, 2002	Substantially Equivalent	ACUSON CORP.
K022292	IMPAX DIAGNOSTIC DISPLAY STATION,IMPAX CLINICAL REVIEW STATION,IMPAX FOR CARDIOLOGY CLINICAL REVIEW SATATION,IMPAX ORTHO	Sep 12, 2002	Substantially Equivalent	AGFA CORP.
K022789	VIATRONIX V3D EXPLORER	Sep 06, 2002	Substantially Equivalent	VIATRONIX, INC.
K021913	CALSCOR SOFTWARE	Sep 06, 2002	Substantially Equivalent	3D MED CO., LTD.
K021738	FLAT PANEL DISPLAYS, ME SERIES & CCL SERIES	Aug 19, 2002	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K021934	MODIFICATION TO MEDSTATION	Aug 12, 2002	Substantially Equivalent	AISOFTW@RE MEDICAL, S.P.A.
K021583	PATXFER	Aug 12, 2002	Substantially Equivalent	BRAINLAB AG
K022428	QUANTITATIVE BLOOD POOL SPECT (QBS)	Aug 06, 2002	Substantially Equivalent	ADAC LABORATORIES
K022310	ADVANTAGE WINDOWS X-RAY/MR FUSION	Aug 01, 2002	Substantially Equivalent	GE MEDICAL SYSTEMS, INC.
K021236	SURGERY AND ACCESSORIES	Jul 17, 2002	Substantially Equivalent	CAMTRONICS, LTD.
K022109	EIZO, MODEL FC-2091	Jul 12, 2002	Substantially Equivalent	EIZO NANAO CORPORATION
K021191	AUTOALIGN	Jul 12, 2002	Substantially Equivalent	CORTECHS LABS, INC.
K020073	MEDICAL ADMINISTRATOR	Jul 12, 2002	Substantially Equivalent	BARCO NV
K021966	Q LAB SOFTWARE	Jul 02, 2002	Substantially Equivalent	ADVANCED TECHNOLOGY LABORATORIES, INC.
K021314	SCEPTRE-VS	Jul 02, 2002	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K021099	REX, VERSION 1.0	Jun 27, 2002	Substantially Equivalent	POINTDX, INC
K021072	FILMSAVER, NT VERSION 5.03	Jun 06, 2002	Substantially Equivalent	AMERICAN MEDICAL RESOURCES, LTD. (AMR)
K021669	PHYSICIAN'S DESKTOP REVIEW	Jun 05, 2002	Substantially Equivalent	ADAC LABORATORIES
K020449	CARDIONOW CARDIOLOGY WIDE AREA ARCHIVE AND RETRIEVAL SYSTEM	May 10, 2002	Substantially Equivalent	CARDIONOW, INC.
K020546	FUSION 7D	Apr 26, 2002	Substantially Equivalent	MIRADA SOLUTIONS LTD.
K020995	EFILM WORKSTATION WITH MODULES	Apr 12, 2002	Substantially Equivalent	EFILM MEDICAL, INC.
K020058	MEDICAL LE	Apr 04, 2002	Substantially Equivalent	BARCO NV
K020061	IMAGEDESK	Apr 03, 2002	Substantially Equivalent	BARCO NV
K020059	MFCD 118I	Apr 03, 2002	Substantially Equivalent	BARCO NV
K020658	VIATRONIX V3D COLON	Mar 07, 2002	Substantially Equivalent	VIATRONIX, INC.
K020483	ADVANTAGE WORKSTATION 4.1	Feb 28, 2002	Substantially Equivalent	GE MEDICAL SYSTEMS
K012439	DENTALEYE 2 DENTAL IMAGE MANAGEMENT SYSTEM	Feb 06, 2002	Substantially Equivalent	RADCO DATA AB
K013994	MODIFICATION TO VIEWSEND MEDICAL	Feb 01, 2002	Substantially Equivalent	KLT TELECOM, INC.
K020140	VOXAR'S CALCIUM SCORING PRODUCT	Jan 28, 2002	Substantially Equivalent	VOXAR LIMITED
K013922	CORONIS 3MP MEDICL FLAT PANEL DISPLAY SYSTEM	Jan 28, 2002	Substantially Equivalent	BARCO NV
K013841	3DFIS, MODEL IES-FL-101	Jan 17, 2002	Substantially Equivalent	3DSHARP, INC.
K013574	ACCENT	Jan 15, 2002	Substantially Equivalent	CONFIRMA, INC.
K014058	ENTEGRA PE PERSONAL DIGITAL ASSISTANT	Dec 21, 2001	Substantially Equivalent	GENERAL ELECTRIC MEDICAL SYSTEMS
K013419	NICOLET ELECTROMAGNETIC NAVIGATION SYSTEM	Dec 20, 2001	Substantially Equivalent	NICOLET BIOMEDICAL
K012327	CSIST DICOM GATEWAY/IMAGE MANAGER	Dec 20, 2001	Substantially Equivalent	CSIST
K013878	CYBERMED, INC., V-WORKS	Dec 07, 2001	Substantially Equivalent	CYBERMED, INC.
K013098	KIMAX REMOTE VIEWING STATION	Dec 07, 2001	Substantially Equivalent	MEDICAL METRICS, INC.
K013630	ISITE RADIOLOGY	Dec 05, 2001	Substantially Equivalent	STENTOR, INC.
K012844	MAROSIS PACS	Nov 08, 2001	Substantially Equivalent	MAROTECH, INC
K011196	IQUANTIFY, VERSION 1.0	Nov 08, 2001	Substantially Equivalent	INSIGHTFUL CORPORATION
K012779	ICONNECTION 3D	Nov 02, 2001	Substantially Equivalent	HINNOVATION, INC.
K012563	DEEP GRAY	Nov 02, 2001	Substantially Equivalent	CORTECHS LABS, INC.
K012475	CAAS II QVA	Oct 24, 2001	Substantially Equivalent	PIE MEDICAL IMAGING B.V.
K012290	RAPIDIA	Sep 28, 2001	Substantially Equivalent	3D MED CO., LTD.
K012093	AETMED IMAGE PROCESSING SOFTWARE	Sep 21, 2001	Substantially Equivalent	AETMED, S.P.A.
K012086	AQUARIUSNET SERVER	Sep 13, 2001	Substantially Equivalent	TERARECON, INC.
K011694	VIEWSTATION	Aug 29, 2001	Substantially Equivalent	IMPAC MEDICAL SYSTEMS, INC.
K012155	KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS	Aug 10, 2001	Substantially Equivalent	EASTMAN KODAK COMPANY
K012211	EFILM WORKSTATION	Jul 31, 2001	Substantially Equivalent	EFILM MEDICAL, INC.
K012099	MONOCHROME PERFECTLY FLAT PANEL DISPLAYS, ME SERIES	Jul 31, 2001	Substantially Equivalent	TOTOKU ELECTRIC CO., LTD
K011582	QCU ANALYTICAL SOFTWARE PACKAGE	Jul 31, 2001	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K012097	VORTEX	Jul 12, 2001	Substantially Equivalent	ULTRAVISUAL MEDICAL SYSTEMS
K012072	VOXAR VC, MODEL 1.0	Jul 12, 2001	Substantially Equivalent	VOXAR LIMITED
K011173	TELEPAX	Jul 11, 2001	Substantially Equivalent	IMED SYSTEMS & CONSULTING, LLC.
K010938	SYNGO MULTIMODALITY WORKSTATION	Jun 26, 2001	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K002911	XSCAN32 TELERADIOLOGY SOFTWARE	Jun 07, 2001	Substantially Equivalent	RADIOGRAPHIC DIGITAL IMAGING, INC.
K010763	GOODNET	May 25, 2001	Substantially Equivalent	GOODMAN CO.,LTD.
K011142	AQUARIUS WORKSTATION	May 08, 2001	Substantially Equivalent	TERARECON, INC.
K010726	MODIFICATION TO MIRAGE	Apr 26, 2001	Substantially Equivalent	SEGAMI CORP., INC.
K010259	MEDIFACE PACS	Apr 26, 2001	Substantially Equivalent	MEDIFACE CO., LTD.
K010271	THINKINGNET	Apr 03, 2001	Substantially Equivalent	THINKING SYSTEMS CORP.
K010571	ADC QS/IPD WORKSTATION	Mar 28, 2001	Substantially Equivalent	AGFA CORP.
K010058	IMAGE IV DICOM IMAGE ARCHIVAL PACS NETWORK	Mar 21, 2001	Substantially Equivalent	WITT BIOMEDICAL CORPORATION
K002789	MEDEVIEW SYSTEM	Mar 21, 2001	Substantially Equivalent	MEDEVIEW.COM
K003746	3D-DOCTOR	Mar 13, 2001	Substantially Equivalent	ABLE SOFTWARE CORP.
K003762	ALI 3D TOOL MODULE FOR MEDICAL IMAGES	Feb 28, 2001	Substantially Equivalent	A.L.I. TECHNOLOGIES, INC.
K010336	ADVANTAGE WINDOWS CT/PET FUSION	Feb 16, 2001	Substantially Equivalent	GE MEDICAL SYSTEMS, INC.
K003607	ONYX-RAD TELEMEDICINE PACS	Feb 15, 2001	Substantially Equivalent	VIZTEK, INC.
K003510	INSTATRAK SYSTEM WITH FLUOROCAT, MODEL IT3500	Feb 12, 2001	Substantially Equivalent	VISUALIZATION TECHNOLOGY, INC.
K003437	ODYSSEY LX, MODEL 211320	Feb 02, 2001	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K003688	VIEW READING STATION	Jan 22, 2001	Substantially Equivalent	ELECTROMED INTL., LTD.
K003459	PHILIPS EASY VISION FAMILY WORKSTATION OPTION MR QUANTITATIVE FLOW	Jan 22, 2001	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K003484	NETRA WORKSTATION AND NETRAMD SOFTWARE	Jan 19, 2001	Substantially Equivalent	SCIMAGE, INC.
K002942	PHILIPS EASY VISION FAMILY WORKSTATION OPTION CARDIRAC SCORING	Dec 19, 2000	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K001550	EBT ULTRAFAST CT SCANNER SYSTEM; C-100, C-150, C-150LXP OR C-150XP SCANNER SYSTEMS; ELECTRON BEAM SCANNER SYSTEM; ELECTR	Dec 11, 2000	Substantially Equivalent	IMATRON, INC.
K002894	MEDIPRIME	Dec 05, 2000	Substantially Equivalent	ALGOTEC SYSTEMS, LTD.
K002782	HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION	Dec 05, 2000	Substantially Equivalent	NUCLEAR DIAGNOSTICS AB
K001947	T.I.M.S., VERSION 2.00	Nov 22, 2000	Substantially Equivalent	TOTAL MEDICAL INFORMATION MANAGEMENT SYSTEMS, INC.
K002780	VIATRONIX VISUALIZATION SYSTEM (VVS)	Nov 17, 2000	Substantially Equivalent	VIATRONIX, INC.
K002724	NUMALINK	Nov 17, 2000	Substantially Equivalent	NUMA, INC.
K002597	CN ACQUISITION STATION	Nov 17, 2000	Substantially Equivalent	CARDIONOW, INC.
K002590	CEDARA CARDIOLOGY VIEWER, CARDIOLOGY ARCHIVE VIEWER, CARDIOLOGY CD VIEWER	Oct 31, 2000	Substantially Equivalent	CEDARA SOFTWARE CORP.
K002424	3D ANGIOGRAPHIC IMAGING SYSTEM, MODEL XIDF-100A	Oct 27, 2000	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K002519	VITREA 2, VERSION 2.1	Oct 19, 2000	Substantially Equivalent	VITAL IMAGES, INC.
K002936	MODIFICATION TO IDS5 IMAGE DISPLAY SYSTEM	Oct 17, 2000	Substantially Equivalent	SECTRA-IMTEC AB
K002144	MEDLINK DIAGNOSTIC OFFLINE WORKSTATION	Sep 28, 2000	Substantially Equivalent	ADVANCED TECHNOLOGY LABORATORIES, INC.
K002039	ECAT PET SCANNER, MODELS ECAT EXACT AND ECAT EXACT HR+ AND ECAT ART	Sep 27, 2000	Substantially Equivalent	CTI PET SYSTEMS, INC.
K002100	XIMX SYSTEM	Aug 25, 2000	Substantially Equivalent	MEDICAL MANAGER RESEARCH DEVELOPMENT
K001753	MEDIS 5MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM	Jul 27, 2000	Substantially Equivalent	BARCO NV DISPLAY SYSTEMS
K001748	MEDIS 5MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM	Jul 27, 2000	Substantially Equivalent	BARCO NV DISPLAY SYSTEMS
K001750	MEDIS 5MP1H QUAD-HEAD MEDICIAL DIAGNOSTIC DISPLAY SYSTEM	Jul 21, 2000	Substantially Equivalent	BARCO NV DISPLAY SYSTEMS
K001754	MEDIS 5MP1H DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM	Jul 19, 2000	Substantially Equivalent	BARCO NV DISPLAY SYSTEMS
K001752	MEDIS 55MP1H SINGLE-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM	Jul 19, 2000	Substantially Equivalent	BARCO NV DISPLAY SYSTEMS
K001751	MEDIS 2MP2 QUAD-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM	Jul 19, 2000	Substantially Equivalent	BARCO NV DISPLAY SYSTEMS
K001747	MEDIS 2MP2 DUAL-HEAD MEDICAL DIAGNOSTIC DISPLAY SYSTEM	Jul 13, 2000	Substantially Equivalent	BARCO NV DISPLAY SYSTEMS
K001596	LIFERX	Jul 06, 2000	Substantially Equivalent	BOWDENGS TECHNOLOGIES, LLC.
K001012	DIGITAL INTEGRATION SYSTEM, DIS2000	Jun 13, 2000	Substantially Equivalent	WELLINGTON MEDICAL SYSTEMS, INC.
K000770	PROVIEW MEDICAL IMAGE DISPLAY MODULE	May 16, 2000	Substantially Equivalent	CERNER CORP.
K000630	MODELS PRIAM (FAMILY OF DEVICES) DIGITAL IMAGING SYSTEM	May 12, 2000	Substantially Equivalent	HOPKINS IMAGING SYSTEMS, INC.
K001140	IDS5 IMAGE DISPLAY SYSTEM	May 03, 2000	Substantially Equivalent	SECTRA AB
K000395	EINSTEIN PROCESSING AND REVIEW WORKSTATION	May 03, 2000	Substantially Equivalent	GE MEDICAL SYSTEMS F.I. HAIFA
K000380	FOTOMASTER	May 03, 2000	Substantially Equivalent	HAMILTON THORNE RESEARCH
K000557	MEDVIZER PACS, MODEL RELEASE 2000	Apr 24, 2000	Substantially Equivalent	VITEL NET
K000443	REMOTE FETAL MEDICINE ULTRASOUND SYSTEM	Apr 24, 2000	Substantially Equivalent	R4 TELEMEDICINE, INC.
K000448	PACSSTATION	Apr 20, 2000	Substantially Equivalent	FERNANDEZ INDUSTRIES, INC.
K000474	VIEW NT	Apr 19, 2000	Substantially Equivalent	ELECTROMED INTL., LTD.
K000293	BARCO MGD 221 2 MEGAPIXEL DIAGNOSTIC DISPLAY	Mar 29, 2000	Substantially Equivalent	BARCO NV
K000292	BARCO MWD 321 PLUS MEDICAL WORKSTATION DISPLAY	Mar 29, 2000	Substantially Equivalent	BARCO NV
K000294	MFCD 120	Mar 27, 2000	Substantially Equivalent	BARCO NV
K000291	MFCD 118	Mar 27, 2000	Substantially Equivalent	BARCO NV
K000016	BARCOMED 5MP2	Mar 14, 2000	Substantially Equivalent	BARCO NV
K000014	BARCOMED 5MP1H	Mar 14, 2000	Substantially Equivalent	BARCO NV
K994270	INSTATRAK 3000 SYSTEM WITH FLUOROTRAK MODULE, MODEL IT3000	Mar 09, 2000	Substantially Equivalent	VISUALIZATION TECHNOLOGY, INC.
K993946	PEGASYS ULTRA	Mar 09, 2000	Substantially Equivalent	ADAC LABORATORIES
K994228	REMOTEIMAGE SYSTEM	Feb 22, 2000	Substantially Equivalent	ETRAUMA.COM CORP.
K994054	ISSA PHAROS	Feb 14, 2000	Substantially Equivalent	VAMS TEC, D.O.O.
K994210	INTURIS SUITE	Feb 04, 2000	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K000015	BARCOMED 2MP2	Feb 04, 2000	Substantially Equivalent	BARCO NV
K993750	PROSOLV ECHOVIEWER, PROSOLV ECHOVIEWER SE, PROSOLV ECHOANALYZER, PROSOLV ECHOSERV, PROSOLV ECHO	Feb 02, 2000	Substantially Equivalent	PROBLEM SOLVING CONCEPTS, INC.
K993802	SHARPVIEW IMAGE ENHANCEMENT SYSTEM	Jan 18, 2000	Substantially Equivalent	CONTEXTVISION AB
K993338	INTEGRATED DIGITAL MEDICAL RECORD (IDMR)	Dec 29, 1999	Substantially Equivalent	IBM ISRAEL LTD.
K993283	OSCAR NET/CD, MODEL M1.82 600 . O/A/B/C	Dec 29, 1999	Substantially Equivalent	ARNOLD & RICHTER CINE TECHNIK
K993761	CARDIOVASCULAR MEASUREMENT SYSTEM - VIEW	Dec 28, 1999	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K993227	PHILIPS INTURIS DICOM RECORDER	Dec 21, 1999	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K993532	DDS, DS3000, RS3000, CS5000, OT3000, IS3000, RS5000, CD3000, US3000, (AMONGST OTHER NAMES)	Dec 15, 1999	Substantially Equivalent	IMPAX TECHNOLOGY, INC.
K993530	SYSTEM 2100	Dec 15, 1999	Substantially Equivalent	MATH SOLUTIONS, LLC.
K992925	AX WORKSTATION DR-VIEWER SOFTWARE OPTION	Nov 23, 1999	Substantially Equivalent	SIEMENS CORP.
K992886	POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A	Nov 09, 1999	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K992654	PLUG 'N VIEW 3D, VERSION 1.0	Nov 05, 1999	Substantially Equivalent	VOXAR LIMITED
K992666	VIDEO PLUS SYSTEM, SERIES 95000	Oct 13, 1999	Substantially Equivalent	CAMTRONICS, LTD.
K992354	SNT IMAGE ANALYSIS SYSTEM	Oct 12, 1999	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K992575	CARDIOVASCULAR WORKSTATION, MODEL CWS 5000/CWS 3000	Oct 07, 1999	Substantially Equivalent	INFIMED, INC.
K990241	ACCUIMAGE, ACCUVIEW DIAGNOSTIC IMAGING, WORKSTATION W/ACCUSCORE, ACCUANALYZE, ACCUSCOPE, ACCUSHADE, ACCUVRT, AND ACCUMIP	Sep 23, 1999	Substantially Equivalent	ACCUIMAGE DIAGNOSTICS CORP.
K992306	SAMSUNG RAYPAX DISPLAY WORKSTATION	Sep 22, 1999	Substantially Equivalent	SAMSUNG SDS CO., LTD
K992112	SAMSUNG RAYPAX FILM DIGITIZER	Sep 09, 1999	Substantially Equivalent	SAMSUNG SDS CO., LTD
K992073	AX WORKSTATION	Sep 09, 1999	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K992259	ECHOCARDIOGRAPHY SYSTEM SERIES 95000	Sep 08, 1999	Substantially Equivalent	CAMTRONICS, LTD.
K991738	DIGITAL VIDEO RECORDING SYSTEM	Aug 13, 1999	Substantially Equivalent	KAY ELEMETRICS CORP.
K991629	GE VIEW APPLICATIONS (CONSISTING OF GE VIEWING STATION AND GE EXTENDED VIEWING STATION) VERSION 1.2C	Aug 02, 1999	Substantially Equivalent	GE MEDICAL SYSTEMS, INC.
K991468	IMMERGE IMAGE CORRELATION	Jul 06, 1999	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K991626	WEBRAD COMPUTED RADIOGRAPHY QUALITY ASSURANCE WORKSTATION	Jul 02, 1999	Substantially Equivalent	ANALOGIC CORP.
K991257	FUJI WAVELET COMPRESSION OR FFCOMP IRREVERSIBLE COMPRESSION	Jun 25, 1999	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K991643	IDS4 V3.2 IMAGE DISPLAY SYSTEM	Jun 08, 1999	Substantially Equivalent	OTECH, INC.
K991578	SMARTSPOT 2000	Jun 03, 1999	Substantially Equivalent	CMT MEDICAL TECHNOLOGIES, LTD.
K990455	PHILIPS EASY VISION FAMILY WORKSTATION LEGS OPTION	May 12, 1999	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K990442	ADVANCED DIAGNOSTIC VIEWER (AOX), MODEL VITRED 1.3	May 11, 1999	Substantially Equivalent	VITAL IMAGES, INC.
K990919	STRAIGHT ASPIRATOR, 90 DEGREE ASPIRATOR,45 DEGREE ASPIRATOR,7 FRENCH ASPIRATOR,EXTENDED STRAIGHT ASPIRATOR,13.9 CM STRAG	Apr 15, 1999	Substantially Equivalent	VISUALIZATION TECHNOLOGY, INC.
K990759	VIEW COM	Apr 15, 1999	Substantially Equivalent	ELECTROMED INTL., LTD.
K990052	TEL-ECHO SYSTEM	Feb 19, 1999	Substantially Equivalent	INNOVATIVE MEDICAL SOLUTIONS, INC.
K984215	WELCH ALLYN FRONT-LINE DOC	Feb 11, 1999	Substantially Equivalent	WELCH ALLYN, INC.
K983815	PACSCACHE	Jan 14, 1999	Substantially Equivalent	DOME IMAGING SYSTEMS, INC.
K983529	INSTATRAK 3000	Dec 31, 1998	Substantially Equivalent	VISUALIZATION TECHNOLOGY, INC.
K982535	INSIGHT DIAGNOSTIC IMAGING WORKSTATION	Dec 21, 1998	Substantially Equivalent	NEO IMAGERY TECHNOLOGIES, INC.
K983401	FRAMEWAVE WEB	Dec 15, 1998	Substantially Equivalent	ML STRATEGIES, INC.
K983392	DATA RAY CORPORATION DR11021 MEDICAL IMAGING MONITOR	Dec 15, 1998	Substantially Equivalent	DATA RAY
K983256	ADVANTAGE WINDOWS (AW) FUSION	Dec 15, 1998	Substantially Equivalent	GE MEDICAL SYSTEMS
K983821	PHILIPS INTURIS CARDIO IMAGE VIEWING PACKAGE	Dec 11, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K984023	MAXVIEW DIAGNOSTIC WORKSTATION	Dec 08, 1998	Substantially Equivalent	DYNAMIC HEALTHCARE TECHNOLOGIES, INC.
K982976	ULTRASOUND WORKSTATION, UIWS-300A	Nov 24, 1998	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K983111	XRAY VISION	Nov 16, 1998	Substantially Equivalent	APTERYX, INC.
K982994	SKULL BASE INSTATRAK SYSTEM	Nov 16, 1998	Substantially Equivalent	VISUALIZATION TECHNOLOGY, INC.
K982769	MITRA IMAGING INC. EXHIBIT	Nov 03, 1998	Substantially Equivalent	MITRA IMAGING, INC.
K982862	RADWORKS MEDICAL IMAGING SOFTWARE WITH QUALITY CONTROL MODULE	Oct 21, 1998	Substantially Equivalent	APPLICARE MEDICAL IMAGING, B.V.
K982820	BARCO MEDIS 5MP 5 MEGAPIXEL MEDICAL DIAGNOSTIC DISPLAY SYSTEM	Oct 08, 1998	Substantially Equivalent	BARCO NV DISPLAY SYSTEMS
K982690	BARCO MEDICAL DISPLAY CONFORMITY AND CONSISTENCY SOFTWARE	Oct 06, 1998	Substantially Equivalent	BARCO NV
K982563	ULTRAPRO MODEL 98	Oct 06, 1998	Substantially Equivalent	RAMSOFT, INC.
K982422	EAGLESOFT CHAIRSIDE	Sep 30, 1998	Substantially Equivalent	EAGLESOFT, A PATTERSON CO.
K983088	INSTACINE D-2000	Sep 22, 1998	Substantially Equivalent	FIDELITY MEDICAL, INC.
K982146	PICTOOLS MEDICAL TOOL KIT MODEL 1.0	Sep 14, 1998	Substantially Equivalent	PEGASUS IMAGING CORP.
K982120	DIGITAL IMAGING SYSTEM, MODELS DIGITREX-1000 AND DIGITREX-2000 (DIGITREX-X000 FAMILY)	Sep 10, 1998	Substantially Equivalent	TREX MEDICAL CORP.
K981998	PEDIATRIC INSTATRAK SYSTEM	Aug 21, 1998	Substantially Equivalent	VISUALIZATION TECHNOLOGY, INC.
K980648	PRO VISION	Jul 20, 1998	Substantially Equivalent	ALGOTEC SYSTEMS, LTD.
K981217	PLATINUM READING, REVIEW & ANALYSIS WORKSTATION	Jun 18, 1998	Substantially Equivalent	GE MEDICAL SYSTEMS
K980234	THE NETWORK SYSTEM	Jun 17, 1998	Substantially Equivalent	MEDICAL SNI LTD.
K980970	IIRAD DIRECTRAY OPERATOR CONSOLE	Jun 08, 1998	Substantially Equivalent	STERLING DIAGNOSTIC IMAGING, INC.
K980168	COMPUTED RADIOGRAPHY QUALITY ASSURANCE SOFTWARE	Apr 02, 1998	Substantially Equivalent	ANALOGIC CORP.
K980118	KODAK DIGITAL SCIENCE ONCOLOGY IMAGE MANAGER	Mar 17, 1998	Substantially Equivalent	EASTMAN KODAK COMPANY
K974755	DYNA VUE 3-D IMAGING PRODUCT	Mar 04, 1998	Substantially Equivalent	IMD SYSTEMS, INC.
K974504	EPS	Feb 27, 1998	Substantially Equivalent	E FOR M IMAGING SYSTEMS DIV., MARQUETTE ELECTRONIC
K980060	ECHOLINK	Feb 25, 1998	Substantially Equivalent	MPACS, LLC.
K974474	PEGASYS INTOUCH	Feb 24, 1998	Substantially Equivalent	ADAC LABORATORIES
K971965	PHILIPS EASYVISION	Jan 30, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K974134	X-SIGHT DIGITAL IMAGING SYSTEM	Jan 27, 1998	Substantially Equivalent	STALLION TECHNOLOGIES, INC.
K974207	PHILIPS EASYVISION WORKSTATION	Jan 22, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K974086	KODAK DIGITAL SCIENCE CARDIAC VIEWER	Jan 20, 1998	Substantially Equivalent	EASTMAN KODAK COMPANY
K973983	PHILLIPS EASY VISION FAMILY WORKSTATION OPTION ENDO 3D	Jan 08, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K973835	PHILIPS EASYVISION WORKSTATION	Jan 06, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K973653	SEEMOR - DISPLAY & PROCESSING PROGRAM EXECUTING ON PERSONAL COMPUTER SYSTEM	Dec 12, 1997	Substantially Equivalent	AREEDA ASSOC., LTD.
K973148	MACOM	Nov 20, 1997	Substantially Equivalent	A. STEIN - REGULATORY AFFAIRS CONSULTING
K972215	MEDIMAGE	Nov 19, 1997	Substantially Equivalent	VEPRO - COMPUTERSYSTEME GMBH
K973065	REALVIEW TELEMEDICINE SYSTEM	Nov 13, 1997	Substantially Equivalent	VCOM SYSTEMS, INC.
K973010	REALTIME 3D DIAGNOSTIC WORKSTATION	Nov 10, 1997	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K973081	DIGITIZER DIRECTOR: IMAGE COMPRESSION MODULE (HO4059-REV 2.0)	Nov 05, 1997	Substantially Equivalent	HOWTEK, INC.
K972933	VOX/BASE FOR WINDOWS	Oct 27, 1997	Substantially Equivalent	J-MAC SYSTEM, INC.
K972886	MIRAGE	Oct 01, 1997	Substantially Equivalent	SEGAMI CORP., INC.
K972520	OPTIVIEW	Sep 29, 1997	Substantially Equivalent	OPTIMED TECHNOLOGIES, INC.
K972256	FCR FUJI COMPUTED RADIOGRAPHY DMS CRT IMAGE CONSOLE HI-C654 (FOR NETWORKS)	Sep 12, 1997	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K972103	PHILIPS EASYVISION	Sep 02, 1997	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K971973	KODAK DIGITAL SCIENCE PRO-MEDICAL THERMAL PRINTER	Aug 25, 1997	Substantially Equivalent	EASTMAN KODAK COMPANY
K971776	ECHOVACS	Jul 14, 1997	Substantially Equivalent	VMI TECHNOLOGIES
K965179	INSIGHT DIAGNOSTIC IMAGING WORKSTATION NIT-DU0-ZOO	Jul 03, 1997	Substantially Equivalent	NEO IMAGERY TECHNOLOGIES, INC.
K971368	IDS4 IMAGE DISPLAY SYSTEM SERIES	Jun 26, 1997	Substantially Equivalent	OTECH, INC.
K971714	NDC DENTAL SYSTEM, VERSION 1.5 X-RAY AND VIDEO	Jun 20, 1997	Substantially Equivalent	NATIONAL DATA CORP.
K971290	STRATASYS FDM MEDMODELER SYSTEM	Jun 20, 1997	Substantially Equivalent	PALADIN MEDICAL, INC.
K970964	MAESTRO DIGITAL IMAGE AND PATIENT RECORD STORAGE SYSTEM	Jun 13, 1997	Substantially Equivalent	INTERNATIONAL IMAGING ELECTRONICS
K970813	DIMS (DIGITAL IMAGING AND MEDICAL SYSTEM) CL1-5110/5111	May 08, 1997	Substantially Equivalent	DENVU, INC.
K970623	IMMERGE IMAGE CORRELATION	Apr 28, 1997	Substantially Equivalent	SURGICAL NAVIGATION TECHNOLOGIES, INC.
K970617	CT-MODELLER SYSTEM	Apr 21, 1997	Substantially Equivalent	MATERIALISE N.V.
K970451	DOWNSCAN 120	Apr 07, 1997	Substantially Equivalent	MERLIN ENGINEERING WORKS, INC.
K970534	PICTURE ARCHIVING & COMMUNICATIONS DEVICE	Apr 04, 1997	Substantially Equivalent	MULTIMEDIA SOLUTIONS
K970450	UPSCAN 120	Apr 01, 1997	Substantially Equivalent	MERLIN ENGINEERING WORKS, INC.
K970349	FUJI MEDICAL LASER IMAGER MF PRINT SERVER MF-PS667	Mar 31, 1997	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K970402	DOCTORS REVIEW SYSTEM	Mar 26, 1997	Substantially Equivalent	DIGISONICS, INC.
K962010	EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS	Mar 21, 1997	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K964327	IPU RX-2	Jan 17, 1997	Substantially Equivalent	MEDIREX, INC.
K962153	DIGITAL IMAGE ANALYSIS SYSTEM	Jan 17, 1997	Substantially Equivalent	UNIVERSITY OF WASHINGTON
K963980	PHILIPS EASYVISION	Dec 23, 1996	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K964124	PHILIPS COMPUTED RADIOGRAPHY	Dec 18, 1996	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K963859	QLVA PLUS	Dec 18, 1996	Substantially Equivalent	SANDERS DATA SYSTEMS, LLC.
K963697	ADVANCED DIAGNOSTIC VIEWER (ADV)	Nov 27, 1996	Substantially Equivalent	BIO-VASCULAR, INC.
K963610	AKI COMPACS DATA COMPRESION MODULE FOR DIAGNOSTIC IMAGES	Nov 27, 1996	Substantially Equivalent	A.L.I. TECHNOLOGIES, INC.
K961740	KODAK DIGITAL SCIENCE MEDICAL PRINTER INTERFACE UNIT	Nov 14, 1996	Substantially Equivalent	KODAK HEALTH IMAGING SYSTEMS, INC.
K961739	KODAK DIGITAL SCIENCE MEDICAL MODALITY ACQUISITION UNIT	Nov 14, 1996	Substantially Equivalent	KODAK HEALTH IMAGING SYSTEMS, INC.
K963037	PATRIOT	Sep 27, 1996	Substantially Equivalent	INFIMED, INC.
K962589	AURORA DIAGNOSTIC WORKSTATION	Sep 20, 1996	Substantially Equivalent	AURORA TECHNOLOGY, INC.
K962260	REAL-TIME VIDEO CONTRAST ENHANCER	Sep 09, 1996	Substantially Equivalent	DIGIVISION, INC.
K961983	TRS 2000 TELERADIOLOGY SYSTEM	Aug 13, 1996	Substantially Equivalent	SECTRA-IMTEC AB
K961871	FLOUROSPOT T.O.P.	Jul 31, 1996	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K961637	PICKER MR WORKSTATIONS (VISTAR,MONTAGE AND ONCALL)	Jul 03, 1996	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K961403	LIFE IMAGING SYSTEMS LIS 6000 A	Jul 03, 1996	Substantially Equivalent	LIFE IMAGING SYSTEMS, INC.
K960265	ADVANTAGE WINDOWS WITH FUNCTOOL OPTION	Jul 03, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K961307	SMART SPOT	Jul 01, 1996	Substantially Equivalent	CMT MEDICAL TECHNOLOGIES, LTD.
K953911	PHILIPS EASYVISION	Jun 27, 1996	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K955457	DIGISCAN 2 PLUS	Jun 18, 1996	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K955092	ACCURAD IMAGE MANAGEMENT SYSTEM, AUTORAD, REGUSTRATION STATION, ARCHIVE SERVER, PRINT SPOOLER, ANALOG & DIGITAL ACQUIRE	May 09, 1996	Substantially Equivalent	CEMAX-ICON, INC.
K960946	ECHONET	May 07, 1996	Substantially Equivalent	LOCKHEED MARTIN COMMUNICATIONS SYSTEMS
K960665	ECHO-COM FOR MS-WINDOWS VERSION 2.0	May 07, 1996	Substantially Equivalent	CONE INSTRUMENTS, INC.
K960613	GE ADVANTAGE WINDOWS REVIEW WORKSTATION	Apr 30, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K960071	IMAGEFUSION	Apr 17, 1996	Substantially Equivalent	RADIONICS SOFTWARE APPLICATIONS, INC.
K960330	INSTATRAK	Apr 08, 1996	Substantially Equivalent	VISUALIZATION TECHNOLOGY, INC.
K960043	KODAK CARDIOLOGY DIGITAL ARCHIVE & REVIEW SYSTEM	Mar 27, 1996	Substantially Equivalent	JAMIESON FILM CO.
K954159	DIGITAL IMAGING SYSTEM	Mar 19, 1996	Substantially Equivalent	CAMTRONICS, LTD.
K953616	PREVIEW SURGERY PLANNING SOFTWARE	Feb 27, 1996	Substantially Equivalent	MEDICAL MEDIA SYSTEMS
K954678	PRO VISION	Jan 05, 1996	Substantially Equivalent	ALGOTEC SYSTEMS, LTD.
K954589	CLARK TUT IMAGE PROCESSING SYSTEM	Jan 05, 1996	Substantially Equivalent	CLARK RESEARCH AND DEVELOPMENT, INC.
K955185	GE ADVANTAGE DICOM CR REPROCESSING STATION	Jan 03, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K954860	ECHONET	Dec 21, 1995	Substantially Equivalent	HEARTLAB, INC.
K944612	ACUSTAR I ADVANCED SURGICAL NAVIGATION SYSTEM	Dec 11, 1995	Substantially Equivalent	Codman & Shurtleff, Inc.
K954222	VIDEO ENHANCEMENT UNIT	Dec 08, 1995	Substantially Equivalent	PERKINS MFG. CO.
K954211	CRISPICS	Dec 05, 1995	Substantially Equivalent	MERLIN ENGINEERING WORKS, INC.
K953259	VOXELVIEW	Nov 24, 1995	Substantially Equivalent	VITAL IMAGES, INC.
K954668	HP ECHO IMAGE MANAGEMENT SYSTEM	Nov 22, 1995	Substantially Equivalent	HEWLETT-PACKARD CO.
K953095	PHILIPS EASYVISION	Nov 14, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K951262	OPERATING ARM SYSTEM (OAS)	Nov 13, 1995	Substantially Equivalent	RADIONICS SOFTWARE APPLICATIONS, INC.
K954055	HDX DIGITAL IMAGING SYSTEM	Oct 24, 1995	Substantially Equivalent	IMACOM, INC.
K952862	FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR	Sep 20, 1995	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K952778	CHESHIRE	Sep 06, 1995	Substantially Equivalent	PERCEPTIVE SYSTEMS, INC.
K952313	VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION	Aug 16, 1995	Substantially Equivalent	VARIAN ASSOC., INC.
K953164	ALALYSIS PACKAGE FOR DENTAL APPLICATIONS FOR XPEED, XPRESS, XVISION	Aug 09, 1995	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K945807	HOMEVUE WOUND MONITORING SYSTEM	Aug 07, 1995	Substantially Equivalent	HOMEVUE HEALTH SYSTEMS, INC.
K945188	CEMAX VIPSTATION AND/OR SOFTWARE	Aug 02, 1995	Substantially Equivalent	CEMAX, INC.
K941566	COMPUSPEAK	Jun 30, 1995	Substantially Equivalent	HOGAN & HARTSON
K945582	WITT BIOMEDICAL IMAGE III	Jun 19, 1995	Substantially Equivalent	WITT BIOMEDICAL CORPORATION
K942504	INSTASPOT	May 05, 1995	Substantially Equivalent	FIDELITY MEDICAL, INC.
K945428	SCRIBE(TM) DIAGNOSTIC IMAGING WORKSTATION	Mar 09, 1995	Substantially Equivalent	MULTI-DIMENSIONAL IMAGING, INC.
K946117	MEDICAL IMAGE MANAGEMENT SYSTEM (MIM)	Mar 02, 1995	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS HEALTH SERVICES CORPORAT
K945389	IVR MASTER	Feb 07, 1995	Substantially Equivalent	SHIMADZU CORP.
K925963	IMAGE TRANSPORT SERIES II	Feb 03, 1995	Substantially Equivalent	DATAVIEW IMAGING INTL., INC.
K945388	DFS-700	Jan 30, 1995	Substantially Equivalent	SHIMADZU CORP.
K934572	UNITONE	Dec 15, 1994	Substantially Equivalent	SCITEX CORPORATION LTD.
K940664	PAPER FILM	Nov 15, 1994	Substantially Equivalent	ASTRO OFFICE PRODUCTS, INC.
K941093	SMARTPACS FILMLESS READING AND IMAGE DISTRIBUTION SYSTEM AND CONSULTATION STATION	Nov 07, 1994	Substantially Equivalent	SMARTPACS
K936179	WINRAD TELERADIOLOGY SYSTEM	Aug 25, 1994	Substantially Equivalent	LINE IMAGING SYSTEMS
K941933	ISG MEDICAL IMAGING FAMILY OF WORKSTATIONS (MIFW)	Jul 29, 1994	Substantially Equivalent	I.S.G. TECHNOLOGIES, INC.
K911783	ALLEGRO VIEWING WAND	Apr 07, 1994	Substantially Equivalent	I.S.G. TECHNOLOGIES, INC.
K932564	RADSTAT	Mar 16, 1994	Substantially Equivalent	DIMENSIONAL MEDICINE, INC.
K935694	SIENET DIAGNOSTIC REPORTING CONSOLE VA02 UPGRADE	Mar 07, 1994	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K932371	CEMAX CLINICALVIEW(TM) STATION AND/OR SOFTWARE	Feb 18, 1994	Substantially Equivalent	CEMAX, INC.
K932372	CEMAX VIPSTATION(TM) AND/OR SOFTWARE	Nov 22, 1993	Substantially Equivalent	CEMAX, INC.
K933209	VISIONTOOL	Sep 29, 1993	Substantially Equivalent	EVERGREEN TECHNOLOGIES, INC.
K931376	GAMMACON IMAGE TRANSLATION SYSTEM	Jul 28, 1993	Substantially Equivalent	NUMA CORP.
K925664	SERIES V-SCAN RADIOGRAPHIC FILM SCANNER	Jun 22, 1993	Substantially Equivalent	VISION TEN, INC.
K930527	DENTAL LINK	Jun 21, 1993	Substantially Equivalent	ESCAN, INC.
K920851	MACVIEW	Apr 20, 1993	Substantially Equivalent	DIMENSIONAL MEDICINE, INC.
K924630	SURGICAD(TM) VIEW(TM)	Apr 07, 1993	Substantially Equivalent	SURGICAD CORP.
K924366	PERSONAL DISPLAY SYSTEM	Apr 07, 1993	Substantially Equivalent	VORTECH DATA, INC.
K925793	TELESHARE 910	Feb 26, 1993	Substantially Equivalent	DEJARNETTE RESEARCH SYSTEMS
K922267	PHOTOPHONE(R) MULTI VIEW(TM)	Feb 02, 1993	Substantially Equivalent	IMAGE DATA CORP.
K925465	TELERADIOLOGY DEVICE & COMPONENT OF PACS COMPONENT	Jan 27, 1993	Substantially Equivalent	LIFE CARE IMAGING
K924310	PRESTILIX 1694 D IMAGE INTENSIFIED FLUOROSCCOPIC	Jan 21, 1993	Substantially Equivalent	GE MEDICAL SYSTEMS
K923042	DU PONT LINX HD-25 LASR IMAGER	Nov 09, 1992	Substantially Equivalent	E.I. DUPONT DE NEMOURS & CO., INC.
K923913	NOISE REDUCTION UNIT W/ LAST IMAGE HOLD	Oct 22, 1992	Substantially Equivalent	JMS IMAGING PRODUCTS, INC.
K920319	SIENET IMAGE DISPLAY WORKSTATIONS, IMAGE ACQUISITI	Oct 20, 1992	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K923270	KODAK EKTASCAN IMAGELINK QUALITY CONTROL WORKSTATI	Sep 11, 1992	Substantially Equivalent	EASTMAN KODAK COMPANY
K921484	MEDVISION	Aug 07, 1992	Substantially Equivalent	EVERGREEN TECHNOLOGIES, INC.
K922310	VORTECH'S PERSONAL DISPLAY SYSTEM	Jul 30, 1992	Substantially Equivalent	VORTECH DATA, INC.
K915342	UD 2000 VIDEO OPTION	Jun 10, 1992	Substantially Equivalent	DIAGNOSTIC ULTRASOUND CORP.
K920950	PHILIPS EASYVISION	Apr 27, 1992	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K920309	SIENET DIAGNOSTIC REPORTING CONSOLE	Mar 20, 1992	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K914366	MEDRAD PATHFINDER HR ROADMAPPING SYSTEM	Feb 27, 1992	Substantially Equivalent	MEDRAD, INC.
K915305	OPTION U1 FOR THE DPS-PLUS SYSTEM	Feb 26, 1992	Substantially Equivalent	ADAC LABORATORIES
K915542	QCA PLUS	Jan 24, 1992	Substantially Equivalent	SANDERS DATA SYSTEMS, LLC.
K915237	PHILIPS PCR-ACE SYSTEM	Jan 09, 1992	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K913755	STATVIEW	Nov 19, 1991	Substantially Equivalent	IMAGE SYSTEMS, INC.
K913264	HYDRAVIEW 1000 DIGITAL IMAGE PROCESS/STOR DEVICE	Nov 01, 1991	Substantially Equivalent	MALLINCKRODT GROUP, INC.
K913754	CARDIO 500	Oct 21, 1991	Substantially Equivalent	KONTRON ELEKTRONIK GMBH
K912829	CARDIOTRACE CARDIAC EVALUATION SYSTEMS	Sep 24, 1991	Substantially Equivalent	CINE GRAPHICS, INC.
K911752	ICON TELERADIOLOGY SYSTEM	Jul 31, 1991	Substantially Equivalent	ICON MEDICAL SYSTEMS, INC.
K904519	AGFA DIAGNOSTIC CENTER (ADC)	Jun 21, 1991	Substantially Equivalent	ENHANCED IMAGING TECHNOLOGIES, INC.
K910437	FUJI COMPUTED RADIOGRAPHY SYSTEM FCR 7501	Apr 24, 1991	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K905132	SHIMADZU IMAGE PROCESSOR DFS-500	Apr 16, 1991	Substantially Equivalent	SHIMADZU MEDICAL SYSTEMS
K905801	CEMAX SPARCSTATION IMAGING SOFTWARE AND WORKSTATIO	Mar 22, 1991	Substantially Equivalent	CEMAX, INC.
K905222	CEDARS-SINAI QUANTITATIVE TI-201 ANALYSIS CTQ 2.0	Dec 26, 1990	Substantially Equivalent	NUCCARDIAC SOFTWARE, INC.
K902428	INTEGRATED DIAGNOSTIC SYSTEM W/ADD'L OPTIONS	Nov 19, 1990	Substantially Equivalent	GE MEDICAL SYSTEMS
K904590	KODAK EKTASCAN LASER PRINTER, MODEL 100 XLP	Nov 13, 1990	Substantially Equivalent	EASTMAN KODAK COMPANY
K901422	SCIVIEW SYSTEM, MODEL SC1250 AND PIXIE IMAGING SOF	Aug 21, 1990	Substantially Equivalent	IMAGE SYSTEMS, INC.
K902648	PINNACLE IMAGE PROCESSING SYSTEM	Aug 17, 1990	Substantially Equivalent	MEDASYS, INC.
K903196	IMAGE INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM	Aug 10, 1990	Substantially Equivalent	GENERAL ELECTRIC CO.
K901679	RESUBMITTED ISG 3DMV WORKSTATION	May 29, 1990	Substantially Equivalent	I.S.G. TECHNOLOGIES, INC.
K900851	DIGITAL IMAGE ENHANCEMENT SYSTEM	May 11, 1990	Substantially Equivalent	ATOMIC PRODUCTS CORP.
K900697	CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS	May 11, 1990	Substantially Equivalent	NUCCARDIAC SOFTWARE, INC.
K901158	LITEBOX DIAGNOSTIC REVIEW WORKSTATION	Apr 19, 1990	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K897000	IMAGEMASTER-101(TM)	Mar 23, 1990	Substantially Equivalent	COLUMBIA SCIENTIFIC, INC.
K900586	MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE	Feb 23, 1990	Substantially Equivalent	MEDRAD, INC.
K896050	FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR)	Dec 14, 1989	Substantially Equivalent	FUJIFILM MEDICAL SYSTEM U.S.A., INC.
K892711	QUANTIM 2000I DIGITAL IMAGE ANALYSIS SYSTEM	Dec 14, 1989	Substantially Equivalent	QUANTITATIVE CARDIAC SYSTEMS (QCS), INC.
K894402	HIPGRAPHICS SYSTEM ONE W/ORTHOTOOL	Nov 17, 1989	Substantially Equivalent	HIPGRAPHICS, INC.
K895320	FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE	Nov 01, 1989	Substantially Equivalent	DIGIVISION, INC.
K892397	MODIFIED CEDARS-SINAI QUANTI THALLIUM-201 ANALYSIS	Oct 27, 1989	Substantially Equivalent	NUCCARDIAC SOFTWARE, INC.
K891695	VIEW 1000	Oct 27, 1989	Substantially Equivalent	VIRTUAL IMAGING
K891692	MIP MR	Oct 27, 1989	Substantially Equivalent	KONTRON ELECTRONICS
K891689	MIPRON/UMIPRON	Oct 27, 1989	Substantially Equivalent	KONTRON ELECTRONICS
K892712	MIP/CT IMAGE PROCESSING WORKSTATION	Oct 19, 1989	Substantially Equivalent	KONTRON ELECTRONICS
K893585	14 COLOR VIDEO DISPLAY 211-260-010	Jul 20, 1989	Substantially Equivalent	MENNEN MEDICAL, INC.
K893521	IMLOGIX 1000 IMAGE DISPLAY SYSTEM	Jun 23, 1989	Substantially Equivalent	IMLOGIX A DIV. OF MICROTERM
K892869	ANGIOTEC ZX DIGITAL IMAGE PROCESSOR	May 26, 1989	Substantially Equivalent	ANDROS ANALYZERS, INC.
K884621	DIGISCAN	Apr 26, 1989	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K890397	REDI-VU MODEL RV-386	Apr 14, 1989	Substantially Equivalent	J.D. TECHNICAL SERVICES
K884995	SIEMENS PACS/1-B (OPTICAL DISK OPTION)	Feb 28, 1989	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K885318	DIGITRON 3, LV ANALYSIS PROTCOL	Feb 17, 1989	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K882933	DACA-100	Feb 08, 1989	Substantially Equivalent	VISUAL CYBERNETICS
K883476	VOXEL FLINGER(TM) 3-D IMAGING SYSTEM	Nov 23, 1988	Substantially Equivalent	REALITY IMAGING CORP.
K883604	MEDRAD IMAGE MANAGEMENT SYSTEM (MIMS)	Nov 15, 1988	Substantially Equivalent	MEDRAD, INC.
K882271	CTQ - CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALY	Nov 03, 1988	Substantially Equivalent	NUCCARDIAC SOFTWARE, INC.
K881481	DIGITRON STENOSIS PROTOCOL	Oct 12, 1988	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K881993	PXI (PERSONAL X-RAY IMAGER) 512	Sep 19, 1988	Substantially Equivalent	OKLAHOMA DIGITAL TECHNOLOGIES, INC.
K882205	VIEWPOINT	Aug 11, 1988	Substantially Equivalent	ADAC LABORATORIES
K881017	DPS-33,000 WITH CENTOR OPTION	Aug 11, 1988	Substantially Equivalent	ADAC LABORATORIES
K880169	CEMAX 5000 MULTIDIMENSIONAL IMAGING WORKSTATION	Mar 09, 1988	Substantially Equivalent	CEMAX, INC.
K874865	DAMON D.E.T.E.C.T IMAGE ENHANCER	Dec 23, 1987	Substantially Equivalent	DAMON CORP.
K873646	DIGIVIEWER	Oct 08, 1987	Substantially Equivalent	DIGIVISION, INC.
K872455	DPS-4100 PLUS DIGITAL RADIOGRAPHY SYSTEM	Sep 01, 1987	Substantially Equivalent	ADAC LABORATORIES
K870821	POLYTRON MODELS 1001, 1002 AND 1004	Jul 01, 1987	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K864854	VIEW(TM) IMAGE PROCESSING AND VIEWING STATION	Feb 26, 1987	Substantially Equivalent	VIRTUAL IMAGING
K864519	PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR)	Feb 13, 1987	Substantially Equivalent	PAREXEL INTL. CORP.
K864927	KODAK EKTASCAN IMAGE TRANS SYS T1/R1 SOFTWARE,1.10	Feb 11, 1987	Substantially Equivalent	EASTMAN KODAK COMPANY
K864739	KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM P1	Feb 11, 1987	Substantially Equivalent	EASTMAN KODAK COMPANY
K863132	DIGITAL FLUORICON CARDIAC/VASCULAR QUANTITATIVE	Jan 14, 1987	Substantially Equivalent	GENERAL ELECTRIC CO.
K862294	THE IMAGE/R	Jan 14, 1987	Substantially Equivalent	QUANTUM DIAGNOSTICS, LTD.
K861514	VNA OPTICAL CORRELATOR	Jan 07, 1987	Substantially Equivalent	VNA SYSTEMS, INC.
K862309	PC-DISPLAY	Nov 12, 1986	Substantially Equivalent	HI-TECH MEDICAL SYSTEMS, INC.
K861852	CSI/MPR OR CSI/MPR PLUS	Oct 08, 1986	Substantially Equivalent	COLUMBIA SCIENTIFIC, INC.
K861429	DIGITRON 3V,3VA,3VAC,3 HIGH RESOLUTION UPGRADE	Jul 25, 1986	Substantially Equivalent	SIEMENS GAMMASONICS, INC.
K861279	FLUORO PLUS	Jun 16, 1986	Substantially Equivalent	ADVANTAGE MEDICAL SYSTEMS, INC.
K854810	FC-1000 FLUOROSCOPIC IMAGING COMPUTER	Apr 15, 1986	Substantially Equivalent	INFICON LEYBOLD-HERAEUS, INC.
K855002	KODAK EKTASCAN IMAGE TRANSMISSION SYSTEM	Apr 07, 1986	Substantially Equivalent	EASTMAN KODAK COMPANY
K852284	DIGIRAD SYSTEM 1 AND THE REUSUABLE IMAGE MEDIA	Nov 14, 1985	Substantially Equivalent	DIGI RAD CORP.
K850080	DIGITAL IMAGE PROCESSOR FP-2C	Apr 19, 1985	Substantially Equivalent	EIGEN VIDEO
K843708	ADAC DPS-4070 DIGITAL RADIOGRAPHY SYS	Apr 16, 1985	Substantially Equivalent	ADAC LABORATORIES
K844298	ADAC MODEL DPS-3300M DIGITAL PROCESSING SYSTEM	Mar 01, 1985	Substantially Equivalent	ADAC LABORATORIES
K844037	DIGITAL FLUOROGRAPHIC IMAGING SYSTEM DIGIFORMER	Mar 01, 1985	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS
K844317	DMI CONSOLE	Feb 26, 1985	Substantially Equivalent	DIMENSIONAL MEDICINE, INC.
K844784	DPS-33000 NUCLEAR MEDICINE IMAGING COMPUTER	Feb 01, 1985	Substantially Equivalent	ADAC LABORATORIES
K844783	DPS-3300 MICRO NUCLEAR MEDICINE IMAGING COMPUTER	Feb 01, 1985	Substantially Equivalent	ADAC LABORATORIES
K832895	VISION TWO, ONE/10 ONE/20 &24	Dec 08, 1983	Substantially Equivalent	COMTAL CORP.

FEI Numbers

This FDA classification entry is associated with 609 FEI numbers. Click on an entry to view related FDA registrations.

1000109969: 52 registrations

1000115748: 14 registrations

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1000116912: 176 registrations

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