Product Code: OWB FDA class 2 21 CFR 892.1650

Interventional Fluoroscopic X-Ray System

Radiology

The Interventional Fluoroscopic X-Ray System is a radiology device used for real-time X-ray imaging guidance during interventional procedures such as catheter placements and vascular interventions. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket notification, and is eligible for third-party review. The product code is OWB, with regulation number 892.1650 under the Radiology medical specialty.

View on FDA

510(k)s

320

FEI Numbers

118

Registration Numbers

118

Unique Applicants

115

Years Active

Basic Information

Product Code: OWB
Device Class: FDA class 2
Regulation Number: 892.1650
Medical Specialty: Radiology
Review Panel: RA
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

Definition

Interventional fluoroscopy

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 320 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K252735	C-beam	May 22, 2026	Substantially Equivalent	Pulmera, Inc.
K252503	Intelligent NR	Apr 30, 2026	Substantially Equivalent	Canon, Inc.
K254173	ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS pheno	Apr 24, 2026	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K253752	ARTIS genio floor; ARTIS icono.explore floor	Apr 23, 2026	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K252229	BELLIGER ACE	Apr 02, 2026	Substantially Equivalent	Genoray Co., Ltd.
K252099	Trinias	Mar 24, 2026	Substantially Equivalent	Shimadzu Corporation
K253584	Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging (FOV Extension)	Mar 10, 2026	Substantially Equivalent	Canon Medical Systems Corporation
K252500	CARA System	Feb 20, 2026	Substantially Equivalent	Cara Medical, Ltd.
K251992	ArmSure Fluoroscopic Positioning System	Feb 11, 2026	Substantially Equivalent	Savfe Co. , Ltd.
K254186	Azurion R3.1	Jan 16, 2026	Substantially Equivalent	Philips Medical Systems B.V.
K252068	MC2 Portable X-ray System	Dec 22, 2025	Substantially Equivalent	Oxos Medical
K251893	SKAN C PULSAR	Dec 16, 2025	Substantially Equivalent	Skanray Technologies Limited
K251199	Allia Moveo	Dec 09, 2025	Substantially Equivalent	GE Medical Systems SCS
K250241	Cios Select	Nov 04, 2025	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K251827	Azurion R3.1	Oct 24, 2025	Substantially Equivalent	Philips Medical Systems B.V.
K251602	Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6 with aEvolve Imaging	Oct 10, 2025	Substantially Equivalent	Canon Medical Systems Corporation
K251523	Cios Spin	Jul 29, 2025	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K243432	Vascular Navigation PAD 2.0; Navigation Software Vascular PAD	Jul 22, 2025	Substantially Equivalent	Brainlab AG
K250660	LUMINOS Q.namix T; LUMINOS Q.namix R	Jul 14, 2025	Substantially Equivalent	Siemens Medical Solutions
K251520	Cios Alpha; Cios Flow	Jul 09, 2025	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K243884	TAVIPILOT	Jul 07, 2025	Substantially Equivalent	Caranx Medical
K250010	EXTRON 3; EXTRON 5; EXTRON 7	Jun 10, 2025	Substantially Equivalent	DRTECH Corporation
K243411	Diagnostic X-ray System	May 19, 2025	Substantially Equivalent	Nanjing Perlove Medical Equipment Co., Ltd.
K242731	MasteRad MiniX Mobile Digital Imaging System (Mini-X)	May 16, 2025	Substantially Equivalent	Medicatech USA, Inc.
K250282	Persona C HR	Apr 30, 2025	Substantially Equivalent	A.T.S. Applicazione Tecnologie Speciali S.R.L.
K243376	uAngio AVIVA CX	Apr 28, 2025	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K234067	ImagingRing m (Version 2.0); Loop-X (Version 2.0); Loop-X Mobile Imaging Robot (Version 2.0)	Mar 28, 2025	Substantially Equivalent	Medphoton GmbH
K243646	Ziehm Solo FD	Mar 17, 2025	Substantially Equivalent	Ziehm Imaging GmbH
K243735	Ziehm Vision FD	Mar 13, 2025	Substantially Equivalent	Ziehm Imaging GmbH
K243446	3DXR	Feb 25, 2025	Substantially Equivalent	GE Medical Systems SCS
K243303	Ziehm Vision RFD 3D	Jan 21, 2025	Substantially Equivalent	Ziehm Imaging GmbH
K243328	Ziehm Vision RFD	Jan 15, 2025	Substantially Equivalent	Ziehm Imaging GmbH
K241567	MC2 Portable X-ray System	Dec 06, 2024	Substantially Equivalent	Oxos Medical
K241572	ARTIS icono (VE40A) (floor); ARTIS icono (VE40A) (biplane); ARTIS icono (VE40A) (ceiling); ARTIS pheno (VE40A)	Oct 22, 2024	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K233107	Alphenix, INFX-8000V/B, INFX-8000V/S, V9.5	Aug 30, 2024	Substantially Equivalent	Canon Medical Systems Corporation
K240465	O-arm O2 Imaging System	Jun 21, 2024	Substantially Equivalent	Medtronic Navigation, Inc.
K233230	See Factor CT3	Jun 21, 2024	Substantially Equivalent	Epica International, Inc.
K240224	Zenition 90	May 22, 2024	Substantially Equivalent	Philips Medical Systems Nederlands B.V.
K240199	IntraOp Alignment System	May 22, 2024	Substantially Equivalent	Alphatec Spine, Inc.
K232298	DIGITAL RADIOGRAPHY CXDI-RF Wireless Bl	Apr 26, 2024	Substantially Equivalent	Canon, Inc.
K233748	CIARTIC Move (VB10)	Mar 15, 2024	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K232420	Zenition 30	Feb 16, 2024	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K240099	Ziehm Vision RFD	Feb 05, 2024	Substantially Equivalent	Ziehm Imaging GmbH
K240020	Ziehm Vision FD	Jan 30, 2024	Substantially Equivalent	Ziehm Imaging GmbH
K234109	Ziehm Solo FD	Jan 26, 2024	Substantially Equivalent	Ziehm Imaging GmbH
K231700	Ziehm Vision FD	Dec 15, 2023	Substantially Equivalent	Ziehm Imaging GmbH
K230949	ARTIS pheno (VE30A)	Dec 15, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K230950	ARTIS icono (VE30A)	Dec 14, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K231669	Ziehm Solo FD	Dec 12, 2023	Substantially Equivalent	Ziehm Imaging GmbH
K231692	Ziehm Vision RFD	Nov 20, 2023	Substantially Equivalent	Ziehm Imaging GmbH
K233200	XPLUS 35 Series (XPLUS 35, XPLUS 35FD)	Nov 16, 2023	Substantially Equivalent	GEMSS HEALTHCARE CO., LTD.
K232344	Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR	Oct 11, 2023	Substantially Equivalent	GE Medical Systems SCS
K230871	EXTRON 5; EXTRON 7	Aug 17, 2023	Substantially Equivalent	DRTECH Corporation
K230787	Oscar 15 & Oscar 15i	Jul 20, 2023	Substantially Equivalent	Genoray Co., Ltd.
K231701	Ziehm Vision RFD 3D	Jul 10, 2023	Substantially Equivalent	Ziehm Imaging GmbH
K222998	F3	Jun 20, 2023	Substantially Equivalent	Acrew Imaging, Inc.
K230185	ANT-X System	Jun 01, 2023	Substantially Equivalent	Ndr Medical Technology Pte. , Ltd.
K221344	nView s1 with nav option	Dec 28, 2022	Substantially Equivalent	Nview Medical
K223410	Cios Select (VA21) Flat Panel	Dec 07, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K223409	Cios Select (VA21) Image Intensifier	Dec 06, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K213768	Bolt Navigation System	Dec 01, 2022	Substantially Equivalent	Circinus Medical Technology, LLC
K221281	Multitom Rax	Nov 17, 2022	Substantially Equivalent	Siemens Medical Solutions
K222070	EndoNaut	Oct 25, 2022	Substantially Equivalent	Therenva Sas
K222080	Garion Image-Intensified Fluoroscopic X-Ray System, Mobile	Oct 06, 2022	Substantially Equivalent	Sg Healthcare Co, Ltd.
K222625	Shield System	Sep 30, 2022	Substantially Equivalent	Radiaction , Ltd.
K220342	XIDF-AWS801, Angio Workstation (Alphenix Workstation), V9.3	Sep 27, 2022	Substantially Equivalent	Canon Medical Systems Corporation
K221922	Trinias	Jul 28, 2022	Substantially Equivalent	Shimadzu Corporation Medical Systems Division
K221230	TRON	Jul 28, 2022	Substantially Equivalent	Xoran Technologies, LLC
K221516	ARTIS icono (Ceiling Configuration)	Jul 19, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K220432	ARTIS icono (VE21) System	Jun 29, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K220409	ARTIS pheno (VE21) System	Jun 29, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K221335	D²RS and D²RS 9090	Jun 07, 2022	Substantially Equivalent	Stephanix
K220311	Cardiovascular Angiography System	May 03, 2022	Substantially Equivalent	Allengers Medical Systems Limited
K220946	SURGIVISIO Device	Apr 15, 2022	Substantially Equivalent	Ecential Robotics
K212159	Shield System	Mar 30, 2022	Substantially Equivalent	Radiaction , Ltd.
K220627	SURGIVISIO Device	Mar 18, 2022	Substantially Equivalent	Ecential Robotics
K211780	ZEN-2090 Turbo	Mar 09, 2022	Substantially Equivalent	Genoray Co., Ltd.
K212212	Multitom Rax with True2scale Body Scan Option	Feb 18, 2022	Substantially Equivalent	Siemens Medical Solutions
K213479	D²RS and D²RS 9090	Dec 23, 2021	Substantially Equivalent	Stephanix
K212442	Cydar EV (Series B) and Cydar EV Maps	Dec 03, 2021	Substantially Equivalent	Cydar , Ltd.
K213455	ControlRad Select Model Z	Nov 24, 2021	Substantially Equivalent	Controlrad, Inc.
K212336	Soteria.AI	Nov 17, 2021	Substantially Equivalent	Omega Medical Imaging, LLC
K212956	FDR Cross (DR-XD 3000)	Nov 08, 2021	Substantially Equivalent	Fujifilm Corporation
K212523	VFSS Pro Mobile Digital Imaging System	Nov 05, 2021	Substantially Equivalent	Imagexray, LLC
K211064	nView s1 with nav option	Oct 29, 2021	Substantially Equivalent	Nview Medical
K212813	Zenition 70	Oct 01, 2021	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K212557	Virtual C DRF-NEO Digital Imaging System	Sep 24, 2021	Substantially Equivalent	Portavision Medical, LLC
K212383	EndoNaut	Aug 31, 2021	Substantially Equivalent	Therenva Sas
K211777	ARCO FP-S	Aug 13, 2021	Substantially Equivalent	A.T.S. Applicazione Tecnologie Speciali S.R.L.
K210912	Excelsius3D	Aug 12, 2021	Substantially Equivalent	Globus Medical, Inc.
K211782	ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9	Jul 01, 2021	Substantially Equivalent	Controlrad, Inc.
K211191	Virtual C DRF Digital Imaging System	Jun 24, 2021	Substantially Equivalent	Portavision Medical, LLC
K203535	Trinias	Apr 28, 2021	Substantially Equivalent	Shimadzu Corporation Medical Systems
K210900	Alphenix, INFX-8000C/B, INFX-8000C/S, V9.2	Apr 12, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K203623	StentBoost Mobile	Apr 05, 2021	Substantially Equivalent	Philips India Limited
K202547	Surgivisio system	Mar 26, 2021	Substantially Equivalent	Surgivisio
K210309	Cios Select (VA21) Flat Panel	Mar 05, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K210307	Cios Select (VA21) Image Intensifier	Mar 04, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K201743	ClarifEye R1.0, ClarifEye Needle	Feb 23, 2021	Substantially Equivalent	Philips Medical Systems Nederlands B.V.
K201583	SmartCT R1.0	Feb 09, 2021	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K210055	Cios Alpha	Feb 05, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K210054	Cios Spin	Feb 05, 2021	Substantially Equivalent	Siemens Medical Systems USA, Inc.
K202431	ControlRad Select Model Z	Dec 23, 2020	Substantially Equivalent	Controlrad, Inc.
K203504	Cios Flow	Dec 22, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K203281	Mobile ImagingRing System, IRm, Loop-X Mobile Imaging Robot, Loop-X	Dec 22, 2020	Substantially Equivalent	Medphoton GmbH
K203551	Alphenix, INFX-8000V/B, /S, V9.1	Dec 18, 2020	Substantially Equivalent	Canon Medical Systems Corporation
K202360	Ziehm Vision RFD 3D	Sep 16, 2020	Substantially Equivalent	Ziehm Imaging GmbH
K200218	Digiscan FDX	Jul 13, 2020	Substantially Equivalent	Allengers Medical Systems Limited
K201156	ARTIS pheno (VE2)	Jun 29, 2020	Substantially Equivalent	Siemens Medical Solution USA, Inc.
K200663	ControlRad Trace Model 9	Jun 24, 2020	Substantially Equivalent	Controlrad, Inc.
K201172	CFP-3131, CFP-2222	May 29, 2020	Substantially Equivalent	Mx Imaging, Inc.
K200917	Azurion R2.1	May 01, 2020	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K200074	O-arm O2 Imaging System	Apr 24, 2020	Substantially Equivalent	Medtronic, Inc.
K193326	ARTIS Icono	Apr 16, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K200887	AS-10	Apr 15, 2020	Substantially Equivalent	Canon, Inc.
K200022	FLUSION-9001, Fluoroscopic C-arm Mobile X-ray System	Apr 03, 2020	Substantially Equivalent	Livermoretech, Inc.
K200360	TrackX	Mar 05, 2020	Substantially Equivalent	Track X Technology, LLC
K192182	C015	Jan 17, 2020	Substantially Equivalent	Micronica Srl
K193230	Ziehm Vision FD	Dec 20, 2019	Substantially Equivalent	Ziehm Imaging GmbH
K183144	uMC 560i	Dec 19, 2019	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K190497	Ziehm 8000	Nov 20, 2019	Substantially Equivalent	Ziehm Imaging GmbH
K190768	ARTIS icono	Sep 12, 2019	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K191503	MobileRay Pulse SE Digital Imaging System	Sep 04, 2019	Substantially Equivalent	Portavision Medical, LLC
K182086	ARCO FP	Aug 20, 2019	Substantially Equivalent	A.T.S. Applicazione Tecnologie Speciali S.R.L.
K190064	nView system 1	Jul 08, 2019	Substantially Equivalent	Nview Medical, Inc.
K183109	ControlRad Trace Model 8	May 13, 2019	Substantially Equivalent	Controlrad, Inc.
K190626	SyncVision System	Apr 12, 2019	Substantially Equivalent	Volcano Corporation
K183101	Zenition 50	Dec 31, 2018	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K183040	Zenition 70	Dec 06, 2018	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K181403	Innova IGS 5, Innova IGS 6, Discovery IGS 7, Discovery IGS 7 OR	Nov 02, 2018	Substantially Equivalent	GE Healthcare
K181550	Cios Spin	Oct 30, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K181560	Cios Alpha	Oct 24, 2018	Substantially Equivalent	Siemens Medical Systems USA, Inc.
K182546	Alphenix, INFX-8000H/B, V8.0	Oct 17, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K182415	Alphenix, INFX-8000F/B, V8.0	Sep 28, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K181415	XIDF - AWS801, Angio Workstation (Alphenix Workstation), V8.0	Sep 10, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K181966	SmartPerfusion	Aug 17, 2018	Substantially Equivalent	Philips Medical Systems Nederlands B.V.
K181943	OSCAR (OSCAR Prime, OSCAR Classic)	Aug 17, 2018	Substantially Equivalent	Genoray Co., Ltd.
K181767	Cios Select	Aug 17, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K181407	Artis zee/zeego & Artis Q/Q.zen	Aug 15, 2018	Substantially Equivalent	Siemens Medical Solution USA, Inc.
K181830	Azurion R2.0	Aug 02, 2018	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K181804	Alphenix, INFX-8000C/B, V8.0	Aug 02, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K181670	Alphenix, INFX-8000V/B, V8.0	Jul 25, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K181834	Ultimax-i, DREX-UI80 (V1.60)	Jul 19, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K173631	Intelli-C	Jul 11, 2018	Substantially Equivalent	Nrt X-Ray A/S
K173639	Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax	Apr 02, 2018	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K180473	ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR	Mar 23, 2018	Substantially Equivalent	Ecotron Co., Ltd.
K173736	TrackX	Feb 28, 2018	Substantially Equivalent	Track X Technology, LLC
K172180	OSCAR 15	Feb 09, 2018	Substantially Equivalent	Genoray Co., Ltd.
K171755	CS-series-FP with MX CFP 3131 or MX CFP 2222 Option Radiographic/Fluoroscopy System	Feb 09, 2018	Substantially Equivalent	Omega Medical Imaging, LLC
K173433	ProxiDiagnost N90	Feb 05, 2018	Substantially Equivalent	Philips Medical Systems Dmc GmbH
K173664	Medtronic O-arm O2 Imaging System	Dec 29, 2017	Substantially Equivalent	Medtronic, Inc.
K172863	Infinix-i, INFX-8000V, V7.0	Dec 14, 2017	Substantially Equivalent	Toshibamedical Systems Corporation
K172822	Azurion series R1.2	Nov 22, 2017	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K173314	LessRay System	Nov 16, 2017	Substantially Equivalent	Nu Vasive, Incorporated
K172700	OEC One	Nov 09, 2017	Substantially Equivalent	Ge Hualun Medical Systems Co. , Ltd.
K172646	XIDF-AWS801, Angio Workstation, V7.0	Oct 30, 2017	Substantially Equivalent	Toshibamedical Systems Corporation
K172307	Dynamic Coronary Roadmap 2.0	Oct 24, 2017	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K172574	SyncVision System	Oct 05, 2017	Substantially Equivalent	Volcano Corporation
K171829	EndoNaut	Sep 21, 2017	Substantially Equivalent	Therenva Sas
K170800	NuVasive LessRay with Enhanced Tracking	Aug 18, 2017	Substantially Equivalent	Nu Vasive, Incorporated
K171565	OEC Elite	Aug 10, 2017	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K170832	Ultimax-i, DREX-UI80 V1.60	Jul 21, 2017	Substantially Equivalent	Toshibamedical Systems Corporation
K170909	Infinix INFX-8000V, V6.40	Jun 16, 2017	Substantially Equivalent	Toshiba Medical Systems Coroporation
K170144	StentBoost Live	Jun 07, 2017	Substantially Equivalent	Philips Medical Stystems Nederland BV
K170130	Dynamic Coronary Roadmap	Jun 02, 2017	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K163140	SPINEL 12HD Interventional Fluoroscopic Mobile X-ray System	May 26, 2017	Substantially Equivalent	Gemss Medical Systems Co., Ltd.
K171194	AS-10, CXDI-401RF	May 24, 2017	Substantially Equivalent	Canon, Inc.
K170752	OEC Elite	May 19, 2017	Substantially Equivalent	Oec Medical Systems, Inc.
K163286	ARTIS pheno	Mar 09, 2017	Substantially Equivalent	Siemens Medical Solution USA, Inc.
K163715	Allura Xper R9	Jan 26, 2017	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K162859	Allura Xper FD series and Allura Xper OR Table series	Dec 02, 2016	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K162148	Allura Xper R9	Nov 23, 2016	Substantially Equivalent	Philips Medical Systems Nethrlands BV
K162614	Infinix, INFX-8000V, V6.35	Oct 17, 2016	Substantially Equivalent	Toshibamedical Systems Corporation
K160279	ANYVIEW-500R Fluoroscopic Mobile X-Ray System	Oct 14, 2016	Substantially Equivalent	Ecotron Co., Ltd.
K161976	Ziehm Solo FD	Oct 06, 2016	Substantially Equivalent	Ziehm Imaging GmbH
K161756	SyncVision System	Sep 05, 2016	Substantially Equivalent	Volcano Corporation
K160455	AneurysmFlow	Aug 25, 2016	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K160147	CT TrueView	Aug 10, 2016	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K161839	2D Quantitative Analysis	Jul 29, 2016	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K161563	Allura Xper FD series and Allura Xper OR Table series	Jul 29, 2016	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K160088	Cydar EV	Jul 07, 2016	Substantially Equivalent	Cydar , Ltd.
K153244	Cios Fusion	Mar 07, 2016	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K153232	Cios Select	Feb 10, 2016	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K152697	INFX-8000C, V6.20	Jan 15, 2016	Substantially Equivalent	Toshibamedical Systems Corporation
K153147	Cios Connect	Jan 12, 2016	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K152696	INFX-8000V, V6.20	Jan 12, 2016	Substantially Equivalent	Toshibamedical Systems Corporation
K152785	XIDF-AWS801, Angio Workstation, V6.20	Nov 25, 2015	Substantially Equivalent	Toshibamedical Systems Corporation
K152928	Multitom Rax	Nov 13, 2015	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K151598	VesselNavigator Rel. 1.0	Aug 17, 2015	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K151000	O-Arm O2 Imaging System	Aug 06, 2015	Substantially Equivalent	Medtronic, Inc.
K151904	SyncVision System	Jul 31, 2015	Substantially Equivalent	Volcano Corporation
K150967	XIDF-AWS801, Angio Workstation, V6.10	Jun 18, 2015	Substantially Equivalent	Toshibamedical Systems Corporation
K142740	Ziehm Vision RFD 3D	Apr 06, 2015	Substantially Equivalent	Ziehm Imaging GmbH
K142736	XIDF-AWS801, Angio Workstation, v5.31	Mar 11, 2015	Substantially Equivalent	Toshibamedical Systems Corporation
K142273	EmboGuide	Jan 30, 2015	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K143281	Ultimax-i	Jan 29, 2015	Substantially Equivalent	Toshibamedical Systems Corporation
K143225	INFX-8000V with Wireless Footswitch	Jan 09, 2015	Substantially Equivalent	Toshibamedical Systems Corporation
K142126	EP NAVIGATOR REL. 5.0	Dec 09, 2014	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K140041	ZEN-7000,SYSTEM,FLUROSCOPIC X-RAY SYSTEM	Nov 28, 2014	Substantially Equivalent	Genoray Co., Ltd.
K142243	LessRay with Tracking	Nov 18, 2014	Substantially Equivalent	Saferay Spine, LLC
K142708	VERADIUS UNITY	Oct 22, 2014	Substantially Equivalent	Philips Medical Systems Nethrlands BV
K141574	ARTIS ZEE/ZEEGO SW VC21	Sep 05, 2014	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K141979	ALLURA XPER FD SERIES / ALLURA XPER OR TABLE SERIES	Aug 19, 2014	Substantially Equivalent	Philips Medical Systems Netherland BV
K133535	INFX-8000V, V5.30	Jul 23, 2014	Substantially Equivalent	Toshibamedical Systems Corporation
K133819	VERADIUS	Jul 10, 2014	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K140138	HEARTNAVIGATOR RELEASE 2.0	Jun 10, 2014	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K132027	OEC 9800 PLUS	May 01, 2014	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K133580	ARTIS ONE	Apr 28, 2014	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K133278	DISCOVERY IGS 740	Apr 24, 2014	Substantially Equivalent	GE Medical Systems SCS
K132094	CIOS ALPHA	Mar 11, 2014	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K133292	ALLURA XPER FD; OR TABLE	Mar 05, 2014	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K123508	TRINIAS	Feb 26, 2014	Substantially Equivalent	Shimadzu Corporation
K132147	2D PERFUSION	Dec 16, 2013	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K132558	SYNC-RX SYSTEM	Dec 12, 2013	Substantially Equivalent	Volcano Corporation
K132970	LESSRAY	Nov 29, 2013	Substantially Equivalent	Saferay Spine, LLC
K132305	STENTBOOST REL. 4	Oct 30, 2013	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K130893	XPERCT REL. 3	Sep 06, 2013	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K131263	XPERGUIDE	Jul 24, 2013	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K130638	ALLURACLARITY XPER FD SERIES X-RAY SYSTEM	Jun 28, 2013	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K122644	ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21	May 16, 2013	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K121772	ALLURA 3D-RA REL 6, 3D ROADMAP REL 1, MR-CT ROADMAP REL 1	Mar 21, 2013	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K123529	ARTIS Q AND Q.ZEN- MODULAR ANGIOGRAPHIC SYSTEM	Feb 26, 2013	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K122457	GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS	Jan 02, 2013	Substantially Equivalent	GE Healthcare
K120282	CARDNAV	Dec 10, 2012	Substantially Equivalent	Paieon, Inc.
K123226	LESSRAY	Dec 05, 2012	Substantially Equivalent	Saferay Spine, LLC
K122234	OEC 9900 ELITE	Aug 16, 2012	Substantially Equivalent	Ge Healthcare Surgery GE Oec Medical Systems, Inc.
K121444	FLAT PANEL DETECTOR	Jun 07, 2012	Substantially Equivalent	Canon, Inc. - Medical Equpment Group
K113403	GE DISCOVERY IGS ANGIOGRAPHIC,FLUOROSCOPIC X-RAY SYSTEM	Feb 14, 2012	Substantially Equivalent	GE Medical Systems SCS
K120073	INFX-8000V WITH	Jan 26, 2012	Substantially Equivalent	Toshibamedical Systems Corporation
K113027	SYNGO AORTIC VALVEGUIDE SOFTWARE	Nov 22, 2011	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K111551	OEC(R) 9800, OEC(R) 9800 PLUS	Oct 04, 2011	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K112180	I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP)	Aug 10, 2011	Substantially Equivalent	Infimed, Inc.
K111344	I5 DIGITAL X-RAY IMAGING SYSTEM (WITH FLAATZ 560)	Jun 10, 2011	Substantially Equivalent	Infimed, Inc.
K103425	ZEN-7000, FLUOROSCOPIC X-RAY SYSTEM	Mar 29, 2011	Substantially Equivalent	Genoray America, Inc.
K103416	NEXUS DRF DIGITAL X-RAY IMAGING SYSTEM	Mar 17, 2011	Substantially Equivalent	Infimed, Inc.
K102529	D2RF DIGITAL DYNAMIC REMOTE SYSTEM	Oct 07, 2010	Substantially Equivalent	Stephanix Radiological Systems
K101868	INFINIX-I INTERVENTIONAL ANGIOGRAPHY SYSTEM MODEL INFX-8000V	Sep 07, 2010	Substantially Equivalent	Toshiba America Medical Systems, In.C
K100102	CS-SERIES-FP	Aug 31, 2010	Substantially Equivalent	Omega Medical Imaging, Inc.
K102005	ALLURA XPER OR TABLE SERIES	Aug 09, 2010	Substantially Equivalent	Philips Medical Systems North America, Inc.
K101833	INFISTITCH FOR I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5	Jul 23, 2010	Substantially Equivalent	Infimed, Inc.
K093066	I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5	Mar 16, 2010	Substantially Equivalent	Infimed, Inc.
K093688	CANON, MODEL URS-50RF	Feb 04, 2010	Substantially Equivalent	Virtual Imaging, Inc.
K092438	ZIEHM SOLO	Dec 23, 2009	Substantially Equivalent	Ziehm Imaging, Inc.
K092439	CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF	Nov 30, 2009	Substantially Equivalent	Virtual Imaging, Inc.
K091918	ZEN-2090 PRO, FLUOROSCOPIC X-RAY SYSTEM, MODEL ZEN-2090 PRO	Oct 07, 2009	Substantially Equivalent	Genoray Co., Ltd.
K092004	GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODEL: 4100IQ, 3100IQ, 2100IQ	Aug 25, 2009	Substantially Equivalent	GE Healthcare
K091658	GE INNOVA SOLID STATE XRAY-IMAGER FLUOROSCOPIC X-RAY SYSTEM, MODELS INNOVA 4100, 3100, 2100, 3131, 2121	Jun 29, 2009	Substantially Equivalent	GE Healthcare
K083545	ZIEHM VISION RFD	May 15, 2009	Substantially Equivalent	Ziehm Imaging, Inc.
K082781	OEC 9900 ELITE	May 01, 2009	Substantially Equivalent	Ge Healthcare Surgery
K090590	VERADIUS, MODEL 718-130	Mar 16, 2009	Substantially Equivalent	Philips Medical Systems North America Co.
K083725	RADPRO ION	Jan 22, 2009	Substantially Equivalent	Virtual Imaging, Inc.
K081073	HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F	Dec 05, 2008	Substantially Equivalent	Pausch, LLC
K082243	PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS	Nov 07, 2008	Substantially Equivalent	General Medical Merate S.P.A
K080847	RFVISION, MODEL 9.9D	Aug 06, 2008	Substantially Equivalent	Almana Medical Imaging
K073543	OEC 9900 ELITE	May 02, 2008	Substantially Equivalent	Ge Oec Medical Systems
K062623	AXIOM LUMINOS DRF	Aug 22, 2007	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K070834	CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)	May 18, 2007	Substantially Equivalent	Omega Medical Imaging, Inc.
K070123	TCA 5R / 5S	Mar 09, 2007	Substantially Equivalent	Dornier Medtech America, Inc.
K062647	E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50	Oct 20, 2006	Substantially Equivalent	Omega Medical Imaging, Inc.
K061953	9900 PLUS MOBILE FLUOROSCOPY SYSTEM WITH 3D AND NAVIGATION OPTIONS	Aug 15, 2006	Substantially Equivalent	Ge Oec Medical Systems
K061534	ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM	Jul 07, 2006	Substantially Equivalent	Ziehm Imaging, Inc.
K061203	ZIEHM VISION R DIGITAL MOBILE IMAGING SYSTEM	Jun 19, 2006	Substantially Equivalent	Ziehm Imaging, Inc.
K061173	CPIVISION DIGITAL IMAGING SYSTEM	Jun 09, 2006	Substantially Equivalent	Communications & Power Industries Canada, Inc.
K061163	INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT	Jun 07, 2006	Substantially Equivalent	Ge Medical Systems, LLC
K052202	AXIOM ARTIS - MODULAR ANGIOGRAPHIC SYSTEM	Mar 07, 2006	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K060259	DIGITAL FLUOROSCOPIC IMAGING SYSTEMS - INNOVA 3131 & INNOVA 2121	Feb 22, 2006	Substantially Equivalent	Ge Medical Systems, LLC
K053279	UROVANTAGE	Dec 22, 2005	Substantially Equivalent	Pck Electronic Industry & Trade Co., Ltd.
K052884	MODEL DFP-8000D/FPD DIGITAL RADIOGRAPHY SYSTEM WITH FLAT PANEL DETECTOR	Oct 26, 2005	Substantially Equivalent	Toshiba America Medical Systems, In.C
K052412	INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ	Sep 16, 2005	Substantially Equivalent	GE Healthcare
K051064	ZIEHM QUANTUM	May 26, 2005	Substantially Equivalent	Ziehm Imaging, Inc.
K050489	INNOVA 2100	Mar 11, 2005	Substantially Equivalent	Ge Medical Systems, LLC
K043076	GE OEC FLUOROSTAR	Dec 22, 2004	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K042793	ARCADIS ORDIC (AVAILABLE WITH OPTIONS 3D AND 3D NAVIGATION INTERFACE)	Oct 29, 2004	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K042053	INNOVA 4100, INNOVA 3100	Aug 26, 2004	Substantially Equivalent	Ge Medical Systems, Inc.
K041931	OEC OLYMPUS MOBILE FLUOROSCOPY SYSTEM WITH INTEGRATED NAVIGATION	Aug 26, 2004	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K041932	OEC OLYMPUS FLUOROSCOPIC IMAGING SYSTEM	Aug 18, 2004	Substantially Equivalent	Ge Oec Medical Systems, Inc.
K041780	NEW BRID	Aug 11, 2004	Substantially Equivalent	Medical Imaging Solutions, Inc.
K041605	PRECISION RXI ANALOG X-RAY SYSTEM	Jun 30, 2004	Substantially Equivalent	General Medical Merate S.P.A
K040675	AXIOM ARTIS U	Jun 10, 2004	Substantially Equivalent	Siemens Medical Systems, Inc.
K032761	KMC-950 C-ARM MOBILE SYSTEM	May 14, 2004	Substantially Equivalent	United Radiology Systems, Inc.
K033737	ALLURA XPER FD20	Dec 09, 2003	Substantially Equivalent	Philips Medical Systems North America, Inc.
K033486	GE PRECISION MPI	Nov 19, 2003	Substantially Equivalent	Nrt-Nordisk Rontgen Teknik A/S
K033244	DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION	Oct 16, 2003	Substantially Equivalent	Ge Medical Systems, Inc.
K031637	INNOVA 3100	Aug 22, 2003	Substantially Equivalent	GE Medical Systems
K032046	PHILLIPS OMNIDIAGNOST ELEVA	Jul 17, 2003	Substantially Equivalent	Philips Medical Systems, Inc.
K030544	RFX FLUROSCOPIC DIGITAL IMAGING SYSTEM	May 21, 2003	Substantially Equivalent	Sigma Vision, Inc.
K030061	PS 3000 DIGATAL PHOTOSPOT SYSTEM	Apr 07, 2003	Substantially Equivalent	Precise Optics
K024200	INNOVA 2000 AND INNOVA 2000S (MOBILE VERSION)	Jan 16, 2003	Substantially Equivalent	Ge Medical Systems, Inc.
K023178	INNOVA 4100	Nov 26, 2002	Substantially Equivalent	Ge Medical Systems, Inc.
K022322	INNOVA AND INNOVA 2000 S	Oct 08, 2002	Substantially Equivalent	Ge Medical Systems, Inc.
K022114	IMPERIUM	Sep 17, 2002	Substantially Equivalent	Elmstech, Inc.
K022069	OEC FLUOROTRAK 9800 PLUS	Sep 17, 2002	Substantially Equivalent	Ge Oec Medical Systems
K021049	OEC 9800 PLUS DIGITAL MOBILE IMAGING SYSTEM	Apr 17, 2002	Substantially Equivalent	Ge Oec Medical Systems
K012490	ORION DIGITAL IMAGING SYSTEM	Feb 12, 2002	Substantially Equivalent	Infimed, Inc.
K013608	DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D	Nov 15, 2001	Substantially Equivalent	Toshiba America Medical Systems, In.C
K011311	UROLOGIC	Jul 10, 2001	Substantially Equivalent	Pck Electronic Industry and Trade Co, Ltd.
K011292	ZIEHM VISION	Jun 20, 2001	Substantially Equivalent	Ziehm International, Inc.
K010942	U04	Apr 12, 2001	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K010435	PHILIPS BV PULSERA/ENDURA	Mar 12, 2001	Substantially Equivalent	Philips Medical Systems, Inc.
K002198	FLUOROSCAN PROFILE, MODEL TCA 4 PLUS; FLUOROSCAN PROFILE IQ, MODEL TCA 4R PLUS	Oct 17, 2000	Substantially Equivalent	Fluoro Scan Imaging Systems, Inc.
K002016	PHILIPS INTEGRIS ALLURA	Sep 06, 2000	Substantially Equivalent	Philips Medical Systems North America, Inc.
K000221	SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE C-ARM	Apr 11, 2000	Substantially Equivalent	Ge Dec Medical Systems
K993037	LCV+ VERSION 2	Feb 14, 2000	Substantially Equivalent	Ge Medical Systems, Inc.
K993687	UROVIEW 2800	Dec 21, 1999	Substantially Equivalent	Ge Dec Medical Systems
K992660	URF DIGITAL - OT	Nov 05, 1999	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K992103	C-QUEST	Sep 01, 1999	Substantially Equivalent	Wuestec Medical, Inc.
K983069	PHILIPS DUO DIAGNOST	Nov 02, 1998	Substantially Equivalent	Philips Medical Systems North America, Inc.
K982993	PHILIPS OMNIDIAGNOST	Sep 29, 1998	Substantially Equivalent	Philips Medical Systems, Inc.
K982427	TREX TILT C-ARM/TABLE MULTIPURPOSE RADIOGRAPHIC/FLUOROSCOPIC POSITIONING SYSTEM, TREX TILT-C	Sep 23, 1998	Substantially Equivalent	Trex Medical Corp.
K974355	INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)	Feb 17, 1998	Substantially Equivalent	Ge Dec Medical Systems
K970734	SIREGRAGH T.O.P. 33 AND SIREGRAPH T.O.P. 40 UNIVERSAL FLUOROSCOPIC X-RAY SYSTEMS	Apr 21, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K970063	SERIES 7600 MOBILE DIGITAL C-ARM	Mar 11, 1997	Substantially Equivalent	Ge Dec Medical Systems
K963952	SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM	Dec 23, 1996	Substantially Equivalent	Ge Dec Medical Systems
K961105	SKIN DOSE MONITOR	Sep 05, 1996	Substantially Equivalent	Mcmahon Medical
K961374	PHILIPS MULTIDIAGNOST 4	Aug 19, 1996	Substantially Equivalent	Philips Medical Systems, Inc.
K960920	CLINIX MP	May 20, 1996	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K921219	PHILIPS DCI-SX	Apr 29, 1994	Substantially Equivalent	Philips Medical Systems, Inc.
K936180	TC+ SYSTEM (TILTING C-ARM SYSTEM)	Mar 16, 1994	Substantially Equivalent	GE Medical Systems
K923049	UROSKOP D1, UROSKOP D2, AND UROSKOP D3	Sep 15, 1992	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K912448	CSP	Aug 28, 1991	Substantially Equivalent	Fischer Imaging Corp.