Product Code: KPS FDA class 2 21 CFR 892.1200

System, Tomography, Computed, Emission

Radiology

This device is an emission computed tomography system, commonly known as a positron emission tomography (PET) or single-photon emission computed tomography (SPECT) scanner, used to produce functional images of metabolic and physiological activity within the body for diagnostic purposes. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification. The product code is KPS, regulated under 21 CFR 892.1200 within the Radiology specialty. This device is eligible for third-party review.

View on FDA

510(k)s

471

FEI Numbers

Registration Numbers

Unique Applicants

130

Years Active

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Basic Information

Product Code: KPS
Device Class: FDA class 2
Regulation Number: 892.1200
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 471 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K261315	Symbia Pro.specta Q3 (11364751);Symbia Pro.specta X3 (11364752);Symbia Pro.specta X7 (11364753);Symbia Pro.specta VA40 Family	May 21, 2026	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K260524	uMI Panvivo (uMI Panvivo LS); uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)	Apr 03, 2026	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K253564	uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S); uMI Panvivo (uMI Panvivo EX); uMI Panvivo (uMI Panvivo ES)	Feb 13, 2026	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K254001	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)	Jan 13, 2026	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.
K253844	AnyScan 3.0 NM Scanner Family	Dec 30, 2025	Substantially Equivalent	Mediso Medical Imaging Systems, Ltd.
K251370	Cartesion Prime (PCD-1000A/3) V10.21	Dec 01, 2025	Substantially Equivalent	Canon Medical Systems Corporation
K251401	PennPET Explorer Positron Emission Tomograph	Nov 25, 2025	Substantially Equivalent	Trustees of the University of Pennsylvania
K252477	Hybrid Viewer (00859873006240)	Sep 09, 2025	Substantially Equivalent	Hermes Medical Solutions AB
K250170	PHAROS	Aug 15, 2025	Substantially Equivalent	Brightonix Imaging
K251561	Biograph Trinion	Jul 31, 2025	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K251839	uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)	Jul 17, 2025	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K251671	Biograph Vision PET/CT Systems; Biograph mCT PET/CT Systems	Jul 03, 2025	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K251153	Aurora	Jun 12, 2025	Substantially Equivalent	Ge Medical Systems Israel
K243881	HeartSee Cardiac P.E.T. Processing Software For Myocardial Perfusion and Coronary Flow Reserve (CFR) Version 4	Mar 03, 2025	Substantially Equivalent	Bracco Diagnostics, Inc.
K241266	Imaging system of positron emission and X-ray computed tomography (DigitMI 930)	Jan 27, 2025	Substantially Equivalent	Raysolution Healthcare Co., Ltd.
K243605	Aurora	Jan 17, 2025	Substantially Equivalent	Ge Medical Systems Israel, Functional Imaging
K243538	uMI Panvivo (uMI Panvivo); uMI Panvivo (uMI Panvivo S)	Dec 12, 2024	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K241364	Hybrid Viewer (00859873006189)	Nov 08, 2024	Substantially Equivalent	Hermes Medical Solutions AB
K243186	Symbia Pro.specta Q3 (11364751); Symbia Pro.specta X3 (11364752); Symbia Pro.specta X7 (11364753); Symbia Pro.specta VA30A Family	Oct 30, 2024	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K241585	uMI Panorama	Aug 30, 2024	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K241596	uMI Panvivo	Aug 15, 2024	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K241665	Omni Legend	Aug 08, 2024	Substantially Equivalent	Ge Medical Systems Israel, Functional Imaging
K241898	Symbia SPECT and SPECT/CT Systems	Jul 26, 2024	Substantially Equivalent	Siemens Healthineers
K241751	NeuroLF (Basic); NeuroLF (Pro); NeuroLF (Advanced); NeuroLF Seat	Jul 15, 2024	Substantially Equivalent	Positrigo AG
K240827	SET-5002	May 24, 2024	Substantially Equivalent	Shimadzu Corporation Medical Systems Division
K231762	uEXPLORER	Jan 18, 2024	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K233677	Biograph VK10	Jan 12, 2024	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K232712	uMI Panorama	Oct 03, 2023	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K232569	CAREMIBRAIN	Sep 21, 2023	Substantially Equivalent	General Equipment For Medical Imaging, S.A.
K231576	cNeuro cPET	Sep 14, 2023	Substantially Equivalent	Combinostics OY
K231748	Cartesion Prime (PCD-1000A/3) V10.15	Sep 12, 2023	Substantially Equivalent	Canon Medical Systems Corporation
K231731	Optional Screen Displays for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 4	Aug 21, 2023	Substantially Equivalent	Mcgovern Medical School
K231572	uMI Panorama	Jul 26, 2023	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K231833	Biograph Vision.X and Biograph Vision.X Edge	Jul 13, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K231102	Symbia Pro.specta VA20A Family	May 17, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K230600	VERITON CT 300 Series Digital SPECT/CT System (VERITON CT 316/364); VERITON CT 400 Series Digital SPECT/CT System (VERITON CT 416/464)	Apr 28, 2023	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.
K223212	Precision DL	Apr 27, 2023	Substantially Equivalent	GE Healthcare
K223422	Emory Cardiac Toolbox 4.3	Mar 30, 2023	Substantially Equivalent	Syntermed
K223325	uMI Panorama	Mar 10, 2023	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K223547	Biograph Vision Quadra PET/CT System	Dec 22, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K222895	DynamicIQ	Nov 22, 2022	Substantially Equivalent	GE Medical Systems SCS
K221932	Omni Legend	Sep 02, 2022	Substantially Equivalent	GE Healthcare
K213731	EFAI CARDIOSUITE SPECT Myocardial Perfusion Agile Workflows	May 31, 2022	Substantially Equivalent	Ever Fortune.Ai, Co., Ltd.
K214062	Radialis PET Camera	Feb 04, 2022	Substantially Equivalent	Radialis, Inc.
K211964	SubtlePET	Sep 28, 2021	Substantially Equivalent	Subtle Medical, Inc.
K212604	Symbia VA10A Family	Sep 16, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K212004	MyoSPECT, MyoSpect ES	Aug 27, 2021	Substantially Equivalent	GE Healthcare
K211846	Discovery MI Gen2	Aug 20, 2021	Substantially Equivalent	Ge Medical Systems, LLC
K211764	Vereos PET/CT	Aug 06, 2021	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K211247	PET VCAR	Jul 27, 2021	Substantially Equivalent	GE Medical Systems SCS
K210880	Vereos PET/CT	May 19, 2021	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K210557	Symbia VA10A Family	May 12, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K210001	HYPER AiR	Apr 30, 2021	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K203314	Cartesion Prime (PCD-1000A/3) V10.8	Apr 23, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K202679	Optional Screen Display for HeartSee Cardiac P.E.T. Processing Software - HeartSee version 3	Apr 12, 2021	Substantially Equivalent	Mcgovern Medical School
K210418	HYPER Focus	Apr 09, 2021	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K210173	StarGuide	Mar 29, 2021	Substantially Equivalent	GE Healthcare
K210450	BBX-PET Scanner	Mar 17, 2021	Substantially Equivalent	Prescient Imaging, LLC
K210262	Biograph Vision Quadra PET/CT System	Mar 03, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K202882	Affinity	Dec 23, 2020	Substantially Equivalent	Hermes Medical Solutions AB
K202392	SIR-Spheres Microspheres Activity Calculator (SMAC)	Oct 23, 2020	Substantially Equivalent	Sirtex Medical US Holdings, Inc.
K202349	Cartesion Prime, PCD-1000A, V10.7	Oct 15, 2020	Substantially Equivalent	Canon Medical Systems Corporation
K201807	ANCORIS	Aug 27, 2020	Substantially Equivalent	Miegmbh
K201933	ImagenSPECT 3.0	Aug 11, 2020	Substantially Equivalent	Cardiovascular Imaging Technologies
K193210	HYPER DLR	Aug 04, 2020	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K200474	Symbia 6.7	Mar 20, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K193248	Biograph Vision, Biograph mCT Family of PET/CTs	Feb 14, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K193152	Affinity	Feb 14, 2020	Substantially Equivalent	Hermes Medical Solutions AB
K192277	CardIQ Flow	Feb 14, 2020	Substantially Equivalent	GE Medical Systems SCS
K193178	Biograph Horizon	Feb 12, 2020	Substantially Equivalent	Siemens Medical Solution USA, Inc.
K193241	Emission Computed Tomography System	Jan 26, 2020	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K191582	Cartesion Prime	Aug 13, 2019	Substantially Equivalent	Canon Medical Systems Corporation
K190457	VERITON CT whole body SPECT/CT system	Jul 12, 2019	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.
K190900	Biograph Vision	May 06, 2019	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K182938	Emission Computed Tomography System	Dec 18, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K182336	SubtlePET	Nov 30, 2018	Substantially Equivalent	Subtle Medical, Inc.
K182484	VERITON CT whole body SPECT/CT system	Nov 09, 2018	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.
K181468	Hybrid3D	Oct 25, 2018	Substantially Equivalent	Hermes Medical Solutions AB
K182237	uMI 550 PET/CT System	Oct 12, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K180077	NeuroQ 3.8	Aug 16, 2018	Substantially Equivalent	Syntermed
K181343	HeartSee Cardiac P.E.T. Processing Software	Jun 12, 2018	Substantially Equivalent	Bracco Diagnostics, Inc.
K180811	Biograph Vision	May 23, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K180514	VERITON NM	Apr 25, 2018	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.
K173816	NM/CT 850, NM/CT 860	Apr 17, 2018	Substantially Equivalent	GE Healthcare
K172143	uMI 780 PET/CT System	Apr 13, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K180318	PET Digital Gating	Apr 11, 2018	Substantially Equivalent	Ge Medical Systems, LLC
K173547	ImagenUniversal	Jan 12, 2018	Substantially Equivalent	Cardiovascular Imaging Technologies
K173578	Biograph mCT Family of PET/CT Systems	Dec 20, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K171719	Hybrid3D	Nov 21, 2017	Substantially Equivalent	Hermes Medical Solutions AB
K171681	Hermes Medical Imaging Suite v5.7	Nov 21, 2017	Substantially Equivalent	Hermes Medical Solutions AB
K173023	Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold	Nov 17, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K172609	CSMC Cardiac Suite	Nov 03, 2017	Substantially Equivalent	Cedars-Sinai Medical Center
K172406	Ingenuity TF	Oct 06, 2017	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K171303	Added Screen Displays For FDA Cleared HeartSee Cardiac P.E.T Processing Software K143664	Sep 22, 2017	Substantially Equivalent	University of Texas Medical School AT Houston, Texas
K170904	Biograph Horizon PET/CT	Jun 01, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K170490	Celesteion, PCA-9000A/3	Jun 01, 2017	Substantially Equivalent	Toshibamedical Systems Corporation
K163394	Hybrid3D	May 22, 2017	Substantially Equivalent	Hermes Medical Solutions AB
K162483	Symbia Intevo Bold	Jan 09, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K161740	D-SPECT Scanner, D-SPECT L Scanner	Nov 04, 2016	Substantially Equivalent	Spectrum Dynamics Medical, Ltd.
K162736	Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CT	Oct 25, 2016	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K161674	QuantumCam	Oct 20, 2016	Substantially Equivalent	Ddd-Diagnostic A/S
K162337	Symbia 6.5	Sep 08, 2016	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K161574	Discovery MI	Aug 11, 2016	Substantially Equivalent	Ge Medical Systems, LLC
K161631	MAMMI	Jul 28, 2016	Substantially Equivalent	General Equipment For Medical Imaging
K153056	Hermes Medical Imaging Suite v5.6	Jun 01, 2016	Substantially Equivalent	Hermes Medical Solutions AB
K160120	D-SPECT Processing and Reviewing Workstation	Mar 21, 2016	Substantially Equivalent	Spectrum Dynamics , Ltd.
K152503	ImagenSPECT	Jan 25, 2016	Substantially Equivalent	Cardiovascular Imaging Technologies
K153402	Discovery NM/CT 670 CZT	Jan 21, 2016	Substantially Equivalent	GE Healthcare
K152880	Biograph Horizon PET/CT	Jan 12, 2016	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K151403	Positron Emission Tomography (PET) and Computed Tomography (CT) System, Positron Emission Tomography (PET) and Computed Tomography (CT) System	Nov 02, 2015	Substantially Equivalent	Neusoft Medical Systems Co., Ltd.
K151486	Biograph mCT and mCT Flow PET/CT Scanners	Jul 17, 2015	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K143664	HeartSee	Apr 14, 2015	Substantially Equivalent	University of Texas Medical School AT Houston
K142631	Hermes Medical Imaging Suite v5.5	Dec 18, 2014	Substantially Equivalent	Hermes Medical Solutions AB
K141477	DISCOVERY IQ	Sep 18, 2014	Substantially Equivalent	Ge Medical Systems, LLC
K141074	CORTEX ID SUITE	Sep 18, 2014	Substantially Equivalent	Ge Medical Systems, LLC
K141971	BIOGRAPH TRUE PET/CT FAMILY SOFTWARE	Sep 12, 2014	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K142006	SYMBIA 6.0	Aug 21, 2014	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K141652	CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE	Jul 22, 2014	Substantially Equivalent	Cedars-Sinai Medical Center
K140996	MAMMI	Jun 11, 2014	Substantially Equivalent	General Equipment For Medical Imaging (Oncovision-
K140651	CELESTEION, PCA-9000A/2	Jun 11, 2014	Substantially Equivalent	Toshibamedical Systems Corporation
K140269	HERMES MEDICAL IMAGING SUITE V5.4	May 08, 2014	Substantially Equivalent	Hermes Medical Solutions AB
K140206	SCINTILLATION GAMMA CAMERA	May 08, 2014	Substantially Equivalent	Ddd-Diagnostic A/S
K133657	DISCOVERY PET/CT 710	Mar 21, 2014	Substantially Equivalent	Ge Medical Systems, LLC
K132347	MULTICAM 3000 ECO	Nov 20, 2013	Substantially Equivalent	Inter Medical Medizintechnik GmbH
K131625	ANYSCAN-S SPECT IMAGING SYSTEM	Oct 03, 2013	Substantially Equivalent	Absolute Imaging Solutions
K131634	SYMBIA	Aug 16, 2013	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K131233	HERMES MEDICAL IMAGING SUITE V5.3	Jul 16, 2013	Substantially Equivalent	Hermes Medical Solutions AB
K123599	INGENUITY DIGITAL PET/CT	Jul 12, 2013	Substantially Equivalent	Philips Healthcare (Cleveland)
K130902	EMORY CARDIAC TOOLBOX 3.2	Jun 14, 2013	Substantially Equivalent	Syntermed, Inc.
K130451	NEUROQ 3.6	May 17, 2013	Substantially Equivalent	Syntermed, Inc.
K130269	ECAT SCINTRON PET	Apr 19, 2013	Substantially Equivalent	Miegmbh
K123433	CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE	Feb 26, 2013	Substantially Equivalent	Cedars-Sinai Medical Center
K123646	EMORY CARDIAC TOOLBOX 4.0	Feb 22, 2013	Substantially Equivalent	Syntermed, Inc.
K123737	BIOGRAPH MCT FAMILY	Jan 29, 2013	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K121278	HERMES MEDICAL IMAGING SUITE V5.2	Dec 18, 2012	Substantially Equivalent	Hermes Medical Solutions AB
K122241	IMAGEN3D	Oct 24, 2012	Substantially Equivalent	Cardiovascular Imaging Technologies
K113754	CFR QUANT	Jul 19, 2012	Substantially Equivalent	University of Texas Medical School AT Houston
K121019	OPTIMA NM/CT 640	Apr 19, 2012	Substantially Equivalent	GE Healthcare
K113408	Q. FREEZE (MOTION VUE2)	Feb 24, 2012	Substantially Equivalent	Ge Medical Systems, LLC
K113086	ACQA	Jan 13, 2012	Substantially Equivalent	Texas Medical Imaging Consultants
K113448	BIOGRAPH MCT FAMILY	Dec 17, 2011	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K113350	BRIVO NM 615	Dec 05, 2011	Substantially Equivalent	GE Healthcare
K112474	CSMC CARDIAC SUITE- NUCLEAR MEDICINE SOFTWARE	Sep 23, 2011	Substantially Equivalent	Cedars-Sinai Medical Center
K110507	CARDIAC SCANNER AND PROCESSING SYSTEM	Jul 13, 2011	Substantially Equivalent	Spectrum Dynamics (Israel) , Ltd.
K111445	DISCOVERY NM 630	Jun 03, 2011	Substantially Equivalent	GE Healthcare
K100714	CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01	Apr 01, 2011	Substantially Equivalent	Cedars-Sinai Medical Center
K103710	WBR XPRESS PET	Jan 19, 2011	Substantially Equivalent	Ultraspect , Ltd.
K101768	MIE SCINTRON GAMMA CAMERA SYSTEMS	Oct 05, 2010	Substantially Equivalent	Miegmbh
K101550	BIOGRAPH MCT FAMILY	Sep 03, 2010	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K101013	MODIFICATION TO SCINTRON IV	Jun 07, 2010	Substantially Equivalent	Miegmbh
K093514	DISCOVERY MODEL NM/CT 670	Dec 10, 2009	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K090811	INSPIRA HD, MODEL: NL1000	Aug 27, 2009	Substantially Equivalent	Neurologica Corporation
K091073	WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS	May 14, 2009	Substantially Equivalent	Ultraspect , Ltd.
K091269	NEUROPET	May 08, 2009	Substantially Equivalent	Photodetection Systems, Inc.
K090178	ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8	Apr 24, 2009	Substantially Equivalent	Neusoft Positron Medical Systems Co., Ltd.
K090553	NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER	Mar 31, 2009	Substantially Equivalent	Naviscan, Inc.
K090403	AUTOSPECT	Mar 31, 2009	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K083852	BIOGRAPH 16 TRUE POINT SYSTEMS	Mar 23, 2009	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K083649	CARDIUS 3 X-ACT	Mar 09, 2009	Substantially Equivalent	Digirad Corp.
K082904	STASYS MOTION CORRECTION SOFTWARE	Dec 17, 2008	Substantially Equivalent	Digirad Corp.
K083504	GE DISCOVERY NM/CT 570C	Dec 12, 2008	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K082506	SYMBIA, VERSION 4.0	Nov 21, 2008	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K082354	STEREO NAVIGATOR ACCESSORY, STN-1000	Nov 18, 2008	Substantially Equivalent	Naviscan Pet Systems
K082581	C-QUEST	Nov 14, 2008	Substantially Equivalent	Medx, Inc.
K082368	CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM	Sep 12, 2008	Substantially Equivalent	Digirad Corp.
K082244	PCA-8000A, MARK 11, PET / CT SYSTEM	Aug 21, 2008	Substantially Equivalent	Toshiba America Medical Systems, In.C
K081453	BIOGRAPH HD FAMILY	Jun 23, 2008	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K081496	OPTIMA PET/CT 560	Jun 12, 2008	Substantially Equivalent	Ge Medical Systems, LLC
K081426	NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE	Jun 04, 2008	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K081201	WBR XPRESS3.CARDIAC	May 28, 2008	Substantially Equivalent	Ultraspect , Ltd.
K080575	CORRIDOR4DM	May 13, 2008	Substantially Equivalent	Invia
K081135	GEMINI CONDOR	Apr 29, 2008	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K080927	BRIGHTVIEW VCT IMAGING SYSTEM	Apr 11, 2008	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K080784	WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE	Apr 02, 2008	Substantially Equivalent	Ultraspect , Ltd.
K072307	QUANTITATIVE NEUROQ 3.0	Mar 14, 2008	Substantially Equivalent	Syntermed, Inc.
K080124	VENTRI 1.1	Jan 31, 2008	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K073021	MULTI-SPECT	Nov 06, 2007	Substantially Equivalent	Eagle Heart Imaging, LLC
K072567	SYMBIA-E, MODEL 10275879	Oct 30, 2007	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K072191	CLEARVISION NUCLEAR MEDICINE IMAGING SYSTEM	Oct 25, 2007	Substantially Equivalent	Gvi Technology Partners
K072468	MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM	Oct 01, 2007	Substantially Equivalent	Spectrum Dynamics , Ltd.
K071503	SYSTEM, TOMOGRAPHY, COMPUTED EMISSION	Jul 26, 2007	Substantially Equivalent	Syntermed, Inc.
K071068	BIOGRAPH 6 TRUEPOINT, MODEL BIOGRAPH 6 - P/N 10238197	May 14, 2007	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K070589	C!	Apr 24, 2007	Substantially Equivalent	Transphoton Corporation
K070542	CARDIUS 1, 2 AND 3 XPO AND 2020TC SPECT IMAGING SYSTEMS	Mar 23, 2007	Substantially Equivalent	Digirad Corp.
K062450	D-SPECT CARDIAC SCANNER SYSTEM	Oct 20, 2006	Substantially Equivalent	Spectrum Dynamics , Ltd.
K062393	GE VANTAGE PET NEURO SOFTWARE	Sep 01, 2006	Substantially Equivalent	GE Healthcare
K062298	APOLLO GAMMA CAMERA SYSTEM	Aug 23, 2006	Substantially Equivalent	Adac Laboratories
K061545	SCENIUM 1.1	Jun 30, 2006	Substantially Equivalent	Siemens Molecular Imaging, Ltd.
K061587	FULLCARD ANALYSIS	Jun 23, 2006	Substantially Equivalent	GE Healthcare
K060486	CYCLONE, MODEL MAICAM 180	Mar 23, 2006	Substantially Equivalent	Spectrica
K060631	BIOGRAPH 64 AND BIOGRAPH 40	Mar 17, 2006	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K060060	BIOGRAPH 6	Feb 03, 2006	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K053086	MIE - GAMMA CAMERA SYSTEMS	Jan 27, 2006	Substantially Equivalent	Mie America, Inc.
K060020	AUTOQUANT PLUS	Jan 20, 2006	Substantially Equivalent	Adac Laboratories
K053062	CARDIARC SPECT IMAGING DEVICE, MODEL CQ103-RV2	Jan 06, 2006	Substantially Equivalent	Cardiarc , Ltd.
K052640	GEMINI RAPTOR	Oct 07, 2005	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K052430	CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM	Oct 04, 2005	Substantially Equivalent	Digirad Corp.
K052434	HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA	Sep 27, 2005	Substantially Equivalent	GE Medical Systems
K051855	VENTRI	Aug 02, 2005	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K051549	CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM	Jul 13, 2005	Substantially Equivalent	Digirad Corp.
K051460	C.CAM-AC	Jun 15, 2005	Substantially Equivalent	Danish Diagnostic Development A/S
K051351	PRECEDENCE SPECT/CT IMAGING SYSTEM	Jun 08, 2005	Substantially Equivalent	Adac Laboratories
K051170	GEMINI GXL	May 23, 2005	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K050815	XACT.CARDIAC & XPRESS.CARDIAC	Apr 26, 2005	Substantially Equivalent	Ultraspect , Ltd.
K050509	LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I	Mar 25, 2005	Substantially Equivalent	Cti Pet Systems, Inc.
K050559	GE DISCOVERY VCT SYSTEM	Mar 17, 2005	Substantially Equivalent	GE Medical Systems
K050366	IMAGENPRO	Mar 17, 2005	Substantially Equivalent	Cardiovascular Imaging Technologies, LLC
K043441	MIRAGE, RELEASE 5.5	Jan 13, 2005	Substantially Equivalent	Segami Corporation
K043381	INFINIA LIGHTSPEED	Dec 23, 2004	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K043293	MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U	Dec 17, 2004	Substantially Equivalent	Acrorad Co., Ltd.
K042863	SCENIUM	Dec 15, 2004	Substantially Equivalent	Siemens Molecular Imaging, Ltd.
K042935	GEMINI GXL	Nov 09, 2004	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K042880	JETSTREAM WORKSPACE	Nov 03, 2004	Substantially Equivalent	Adac Laboratories
K042903	AUTOSPECS	Oct 29, 2004	Substantially Equivalent	Adac Laboratories
K042839	C-PET PLUS IMAGING SYSTEM	Oct 29, 2004	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K042258	BP-SPECT V1.O	Oct 04, 2004	Substantially Equivalent	Syntermed, Inc.
K042467	LSO PET/CT HIREZ 64	Oct 01, 2004	Substantially Equivalent	Cti Pet Systems, Inc.
K042428	SCEPTREP3 PET/CT	Sep 17, 2004	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K042257	DISCOVERY ST PET/CT IMAGING SYSTEM WITH AN ALTERNATE DETECTOR OPTION	Sep 08, 2004	Substantially Equivalent	General Electric Co.
K041840	MEDX NUQUEST - INTECAM SPECT 37-75 SYSTEM	Aug 20, 2004	Substantially Equivalent	Medx, Inc.
K041955	GEMINI PET/CT IMAGING SYSTEM	Jul 29, 2004	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K041671	IMAGENMD	Jul 22, 2004	Substantially Equivalent	Cardiovascular Imaging Technologies, LLC
K041543	GE DISCOVERY ST	Jun 22, 2004	Substantially Equivalent	GE Healthcare
K041022	NEUROQ - PET DP	Jun 17, 2004	Substantially Equivalent	Syntermed, Inc.
K041220	GE DISCOVERY ST SYSTEM	Jun 15, 2004	Substantially Equivalent	GE Medical Systems
K040933	ECAT HRRT	Jun 07, 2004	Substantially Equivalent	Cti Pet Systems, Inc.
K041218	GRIFFIN SPECT/CT IMAGING SYSTEM	May 24, 2004	Substantially Equivalent	Adac Laboratories
K041182	SYNTEGRA	May 21, 2004	Substantially Equivalent	Adac Laboratories
K041166	SIEMENS ENHANCED IMAGING SYSTEM	May 17, 2004	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K040172	MODIFICATION TO GE DISCOVERY LS SYSTEM	Apr 07, 2004	Substantially Equivalent	GE Medical Systems
K040616	CARDIOMD-AC	Mar 24, 2004	Substantially Equivalent	Danish Diagnostic Development A/S
K040370	WBR-FHR, WBR-FWB	Mar 11, 2004	Substantially Equivalent	Ultraspect , Ltd.
K040326	AUTOQUANT PLUS	Feb 25, 2004	Substantially Equivalent	Adac Laboratories
K040057	MOBILE COMPACT DIGITAL CARDIAC CAMERA	Feb 02, 2004	Substantially Equivalent	Is2 Research, Inc.
K040141	EMORY CARDIAC TOOLBOX VERSION 2.6	Jan 30, 2004	Substantially Equivalent	Syntermed, Inc.
K033956	MOBILE SINGLE CIRCULAR CAMERA (MSC) & MOBILE DIGITAL CARDIAC CAMERA (MDCC)	Jan 20, 2004	Substantially Equivalent	Is2 Research, Inc.
K033874	MYOLIGHT	Dec 30, 2003	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K033001	APEX DETECTOR ELECTRONICS & ACQUISITION INTERFACE, MODEL XL-4	Dec 24, 2003	Substantially Equivalent	Transphoton Corporation
K033782	ALLEGRO IMAGING SYSTEM	Dec 19, 2003	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K032779	MODIFICATION TO: NUCAMMA RX	Dec 17, 2003	Substantially Equivalent	Is2 Research, Inc.
K033735	VANTAGE PRO ATTENUATION CORRECTION DEVICE	Dec 12, 2003	Substantially Equivalent	Adac Laboratories
K032866	CLARITY PET	Dec 12, 2003	Substantially Equivalent	Shared P.E.T. Imaging, LLC
K033431	LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ	Nov 20, 2003	Substantially Equivalent	Cti Pet Systems, Inc.
K033199	COMPACT DIGITAL CARDIAC CAMERA (CDCC)	Nov 12, 2003	Substantially Equivalent	Is2 Medical Systems, Inc.
K033254	FORTE GAMMA CAMERA SYSTEM	Oct 22, 2003	Substantially Equivalent	Adac Laboratories
K032500	MODIFICARION TO WACKERS-LIU CQ SOFTWARE	Aug 25, 2003	Substantially Equivalent	Eclipse Systems, Inc.
K032063	PEM 2400 PET SCANNER	Aug 18, 2003	Substantially Equivalent	Pem Technologies
K031874	MODIFICATION TO WBR, MODEL HR	Jul 18, 2003	Substantially Equivalent	U.C.G. Technologies , Ltd.
K032036	GEMINI 16	Jul 11, 2003	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K031872	ULTRA-HIGH ENERGY GENERAL PURPOSE COLLIMATOR (UHGP) [FOR CARDIAC IMAGING]	Jun 20, 2003	Substantially Equivalent	Adac Laboratories
K031825	C.CAM	Jun 20, 2003	Substantially Equivalent	Danish Diagnostic Development A/S
K031705	SKYLIGHT IMAGING SYSTEM	Jun 17, 2003	Substantially Equivalent	Adac Laboratories
K030870	WBR, MODEL HR	Apr 09, 2003	Substantially Equivalent	U.C.G. Technologies , Ltd.
K030199	GE MOBILE DISCOVERY ST PET CT IMAGING SYSTEM	Feb 11, 2003	Substantially Equivalent	General Electric Co.
K030085	CARDIUS-1 AND CARDIS-2	Feb 05, 2003	Substantially Equivalent	Digirad Corp.
K023988	GE DISCOVERY LS SYSTEM	Feb 04, 2003	Substantially Equivalent	GE Medical Systems
K023932	GE PHOTON ENERGY RECOVERY (PER) OPTION	Dec 11, 2002	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K023768	ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16	Nov 25, 2002	Substantially Equivalent	Cti Pet Systems, Inc.
K023110	CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005	Nov 22, 2002	Substantially Equivalent	Digirad Corp.
K023518	ECAT LSO PET/CT 16	Nov 08, 2002	Substantially Equivalent	Cti Pet Systems, Inc.
K022960	GE QUASAR NUCLEAR MEDICINE SYSTEM	Sep 19, 2002	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K022872	GE ROAD WARRIOR PET CT IMAGING SYSTEM	Sep 12, 2002	Substantially Equivalent	General Electric Co.
K021633	ECAT VISION PET SCANNER, MODELS 3000 & 5000	Aug 14, 2002	Substantially Equivalent	Cti Pet Systems, Inc.
K022240	MOBILE MILLENNIUM MG SYSTEM	Aug 06, 2002	Substantially Equivalent	Ge Medical Systems, Inc.
K022001	MPOWER, MODEL 712 SERIES	Jul 12, 2002	Substantially Equivalent	Positron Corp.
K021823	CARDIOSPECT D90/CARDIO CAM	Jun 17, 2002	Substantially Equivalent	Nuclear Cardiology Systems, Inc.
K021656	HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.4	Jun 13, 2002	Substantially Equivalent	Nuclear Diagnostics
K020300	NORTHWESTERN GATED BLOOD POOL SPECT (NUMUGAS)	Apr 23, 2002	Substantially Equivalent	Syntermed, Inc.
K013353	NEUROSPECTQUAD GAMMA CAMERA	Mar 04, 2002	Substantially Equivalent	Nuclear Cardiology Systems, Inc.
K014033	EMORY CARDIAC TOOLBOX 2.1 EXECUTING ON NUCLEAR MEDICINE COMPUTERS	Feb 22, 2002	Substantially Equivalent	Syntermed, Inc.
K013667	BCC GAMMA CAMERA	Jan 28, 2002	Substantially Equivalent	Is2 Research, Inc.
K013496	MODIFICATION TO SKYLIGHT IMAGING SYSTEM	Nov 06, 2001	Substantially Equivalent	Adac Laboratories
K013504	MODIFICATION TO: ECAT LSO PET/CT SCANNER	Oct 31, 2001	Substantially Equivalent	Cti Pet Systems, Inc.
K012775	GE POSITRACE/DISCOVERY VI PET/CT DUAL MODE ONCOLOGY SCANNER	Sep 18, 2001	Substantially Equivalent	GE Medical Systems
K012568	GE VISION NUCLEAR MEDICINE WORKSTATION	Sep 06, 2001	Substantially Equivalent	General Electric Co.
K011572	QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)	Jun 15, 2001	Substantially Equivalent	Digirad Corp.
K011611	CARDIOCAM MODEL 9CSY0799	Jun 08, 2001	Substantially Equivalent	Danish Diagnostic Development A/S
K010509	CEDARS-SINAI BPGS AND MOCO	Apr 27, 2001	Substantially Equivalent	Smv America
K003882	NUCAMMA BI90	Feb 21, 2001	Substantially Equivalent	Is2 Research, Inc.
K010137	ORBITER II CCI/SPECT ORBITER II CCI/SPECT	Feb 13, 2001	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K003358	QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)	Jan 19, 2001	Substantially Equivalent	Smv America
K003849	GE ADVANCE NXI PET SYSTEM	Dec 22, 2000	Substantially Equivalent	Ge Medical Systems, Inc.
K003264	QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION	Dec 21, 2000	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K003241	ECAT PET SCANNER	Dec 13, 2000	Substantially Equivalent	Cti Pet Systems, Inc.
K003434	ALLEGRO TB, ALLEGRO N	Nov 16, 2000	Substantially Equivalent	Adac Laboratories
K002584	ECAT ACCEL PET SCANNER	Nov 16, 2000	Substantially Equivalent	Cti Pet Systems, Inc.
K002715	ECAT PET SCANNER	Oct 31, 2000	Substantially Equivalent	Cti Pet Systems, Inc.
K002229	WACKERS-LIU CQ SOFTWARE	Oct 20, 2000	Substantially Equivalent	Eclipse Systems, Inc.
K002553	DS DS I-SERIES	Sep 15, 2000	Substantially Equivalent	Smv America
K001681	POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM	Aug 25, 2000	Substantially Equivalent	Smv America
K001276	MEDICAL IMAGE MERGE (MIM)	Jul 17, 2000	Substantially Equivalent	Syntermed, Inc.
K001888	UNICORN MODEL SYS0630	Jun 30, 2000	Substantially Equivalent	Danish Diagnostic Development A/S
K001026	3D-MSPECT	Jun 20, 2000	Substantially Equivalent	The Reagents of the University of Michigan
K000908	SKYLIGHT IMAGING SYSTEM	Apr 05, 2000	Substantially Equivalent	Adac Laboratories
K994167	CODE AC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA WITH COINCIDENCE OPTION (CODE)	Mar 07, 2000	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K993893	MEDX INTECAM INTERFACE	Feb 10, 2000	Substantially Equivalent	Medx, Inc.
K992992	AUTOMATIC IMAGE REGISTRATION SOFTWARE, MODEL NSFU-050A	Dec 03, 1999	Substantially Equivalent	Toshiba America Medical Systems, In.C
K992731	E.CAM COMPUTER	Nov 10, 1999	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K992560	MAPS 10000	Oct 29, 1999	Substantially Equivalent	Web Link Medical
K992450	EMORY CARDIAC TOOLBOX* 2.0 EXECUTING ON NUCLEAR MEDICINE COMPUTERS	Oct 07, 1999	Substantially Equivalent	Emory University
K992335	BEACON-P, MODEL 211059	Oct 07, 1999	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K992317	AUTOSPECT PLUS WITH INSTILL MOTION CORRECTION	Oct 01, 1999	Substantially Equivalent	Adac Laboratories
K992078	VANTAGE EXSPECT II	Sep 01, 1999	Substantially Equivalent	Adac Laboratories
K991841	HAWKEYE OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA	Aug 26, 1999	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K991896	MG ATC: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE-ANGLE GAMMA CAMERA	Aug 23, 1999	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K991565	TAC-2, TRANSMISSION ATTENUATION CORRECTION AND DST, DST-XL GAMMA CAMERAS AND VISION POWER STATION COMPUTER, FOR USE IN S	Aug 02, 1999	Substantially Equivalent	Smv America
K991535	CONVERGENCE CDR FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS	Jul 30, 1999	Substantially Equivalent	Hitachi Medical Corp. of America
K991607	VANTAGE 2.5	Jul 26, 1999	Substantially Equivalent	Adac Laboratories
K991318	CONVERGENCE NUA FOR HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERAS	Jun 18, 1999	Substantially Equivalent	Hitachi Medical Corp. of America
K991129	HITACHI SPECTRADIGITAL V250DSP GAMMA CAMERA SYSTEM WITH THICK NAL(TI) CRYSTAL	May 13, 1999	Substantially Equivalent	Hitachi Medical Corp. of America
K983948	BEACON, MODEL 211060	Apr 16, 1999	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K983516	TRANSMISSION KIT, TRANS-CT, MODEL NSTR-050A	Dec 23, 1998	Substantially Equivalent	Toshiba America Medical Systems, In.C
K983514	POSITRON OPTION, MODEL NSCO-050A	Dec 23, 1998	Substantially Equivalent	Toshiba America Medical Systems, In.C
K982911	FORTE	Nov 16, 1998	Substantially Equivalent	Adac Laboratories
K982855	DIGIRAD 2020TC SPECT IMAGING SYSTEM	Nov 04, 1998	Substantially Equivalent	Digirad Corp.
K982387	E.CAM EXTRA HIGH ENERGY COLLIMATOR	Oct 06, 1998	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K981553	AUTOMATED MEDICAL REPORT WRITER	Sep 29, 1998	Substantially Equivalent	Woodson and Associates, LLC
K982300	TRANSVIEW (TRANSMISSION SYSTEM),MODEL NDTR-701A	Sep 25, 1998	Substantially Equivalent	Toshiba America Medical Systems, In.C
K982171	HAMAMATSU PET SCANNER, MODEL SHR-22000	Sep 17, 1998	Substantially Equivalent	Hamamatsu Photonics K.K.
K982045	NUCAMMA RX	Sep 02, 1998	Substantially Equivalent	Is2 Research, Inc.
K982044	NUCAMMA R+	Sep 02, 1998	Substantially Equivalent	Is2 Research, Inc.
K981352	VPC-94 ULTRA HIGH ENERGY COLLIMATERS MODEL NUMBERS 480-685-9402	Jul 13, 1998	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K981291	VANTAGE 3.0 INSYNCH	Jun 29, 1998	Substantially Equivalent	Adac Laboratories
K981027	E.CAM LSO 311 PET/SPECT SYSTEM	Jun 08, 1998	Substantially Equivalent	Cti Pet Systems, Inc.
K980959	VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA	Jun 04, 1998	Substantially Equivalent	Ge Medical Systems F.I. Haifa
K980914	EMORY CARDIAC TOOL BOX	Jun 04, 1998	Substantially Equivalent	Emory University
K980867	3D-MSPECT	Jun 04, 1998	Substantially Equivalent	Adac Laboratories
K980715	AUTOQUANT QUANTITATIVE PERFUSION SPECT (QPS) & QUANTITATIVE GATED SPECT (QGS)	May 06, 1998	Substantially Equivalent	Adac Laboratories
K974256	ECAT PET SCANNERS	Feb 25, 1998	Substantially Equivalent	Cti Pet Systems, Inc.
K974444	NUMASTATION	Feb 13, 1998	Substantially Equivalent	Numa, Inc.
K973396	QUEST PET IMAGING SYSTEM	Jan 21, 1998	Substantially Equivalent	Ugm Medical Systems, Inc.
K973233	IMAGE FUSION AND REVIEW SYSTEM	Nov 25, 1997	Substantially Equivalent	Adac Laboratories
K971980	MCD-AC	Oct 23, 1997	Substantially Equivalent	Adac Laboratories
K972686	VCAR OPTION TO THE DST AND DST-XL GAMMA CAMERAS AND VISION POWERSTATION COMPUTER	Oct 14, 1997	Substantially Equivalent	Smv America
K965226	EXPERT-XL TOTAL BODY ACQUISITION AND ANALYSIS SOFTWARE	Oct 03, 1997	Substantially Equivalent	Lunar Corp.
K972360	MULTISPECT 2 511 KEV COLLIMATOR	Sep 23, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K972509	CEQUAL-QUANTITATIVE ANALYSIS FOR CARDIOLITE EXECUTING ON THE MEDASYS DIGITAL SYSTEMS COMPUTER	Sep 08, 1997	Substantially Equivalent	Nuccardiac Software, Inc.
K970627	E. CAM COINCIDENCE MODE (CM)	Sep 04, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K971878	VANTAGE 2.1 EXSPECT	Aug 08, 1997	Substantially Equivalent	Adac Laboratories
K970970	CARDIOMATCH	Jun 13, 1997	Substantially Equivalent	Focus Medical SA
K964438	511 KEV COLLIMATOR	May 29, 1997	Substantially Equivalent	Trionix Research Laboratory, Inc.
K970288	CLINICAL DIAGNOSTIC SOFTWARE	Apr 24, 1997	Substantially Equivalent	Nuccardiac Software, Inc.
K970128	ISOCAM I (SINGLE HEAD GAMMA CAMERA)/ISOCAM II (DUAL HEAD GAMMA CAMERA)	Apr 11, 1997	Substantially Equivalent	Park Medical Systems, Inc.
K963983	E. CAM PROFILE ATTENUATION CORRECTION	Mar 31, 1997	Substantially Equivalent	Siemens Corp.
K963273	VCAR OPTION TO VISION FX-80 GAMMA CAMERA AND POWER STATION	Mar 11, 1997	Substantially Equivalent	Smv America
K964834	ISOCAM II (DUAL HEAD GAMMA CAMERA)	Feb 28, 1997	Substantially Equivalent	Park Medical Systems, Inc.
K963406	UHE COLLIMATOR (210591)	Feb 26, 1997	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K964712	PRISM XPVT SYSTEM (210823)	Feb 21, 1997	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K963730	PROTEC (1024)	Feb 10, 1997	Substantially Equivalent	Proportional Technologies, Inc.
K962100	VOLMETRIC COINCIDENCE DETECTION SYSTEM	Jan 10, 1997	Substantially Equivalent	Elscint, Inc.
K964012	GENIE PROCESSING AND REVIEW WORKSTATION	Jan 07, 1997	Substantially Equivalent	GE Medical Systems
K960948	SCATTER CORRECTION VOLUME SOFTWARE MODEL NSSC-020A	Dec 23, 1996	Substantially Equivalent	Toshiba Medical Systems
K962481	QUASAR RECOVERY IMAGING PACKAGE	Nov 27, 1996	Substantially Equivalent	Trionix Research Laboratory, Inc.
K964268	TRIAD 88 NUCLEAR IMAGING SYSTEM	Nov 12, 1996	Substantially Equivalent	Trionix Research Laboratory, Inc.
K964267	MONAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM	Nov 12, 1996	Substantially Equivalent	Trionix Research Laboratory, Inc.
K964266	BIAD NUCLEAR IMAGING SYSTEM	Nov 12, 1996	Substantially Equivalent	Trionix Research Laboratory, Inc.
K964265	CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM	Nov 12, 1996	Substantially Equivalent	Trionix Research Laboratory, Inc.
K963162	QUANTEM	Nov 12, 1996	Substantially Equivalent	Elscint, Inc.
K962955	GAMMACON IMAGE TRANSLATION SYSTEM	Oct 28, 1996	Substantially Equivalent	Medical Imaging Technology Assoc., Inc.
K962797	ECAT EXACT & ECAT EXACT HR+	Oct 15, 1996	Substantially Equivalent	Cti Pet Systems, Inc.
K962738	MILLENNIUM MT AND MILLENNIUM MG NUCLEAR MEDICINE SYSTEMS	Oct 10, 1996	Substantially Equivalent	GE Medical Systems
K960865	STEP OPTION TO PRISM 2000	Sep 20, 1996	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K960192	POSITRON COINCIDENCE DETECTION	Sep 12, 1996	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K961597	GATED MIBI 3-D EJECTION FRACTION PROCESSING	Sep 04, 1996	Substantially Equivalent	Trionix Research Laboratory, Inc.
K961577	PRISM 3000XPV SYSTEM (210714)	Jul 23, 1996	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K955484	XENON OPTION TO PRISM 3000	Mar 29, 1996	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K954874	SPECTEF PROTOCOL	Feb 26, 1996	Substantially Equivalent	GE Medical Systems
K952190	TRANSMISSION ATTENUATION CORRECTION (TAC) PACKAGE	Jan 18, 1996	Substantially Equivalent	Sopha Medical Systems, Inc.
K954143	HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS	Dec 22, 1995	Substantially Equivalent	Hitachi Medical Corp. of America
K954129	SPECTRADIGITAL SERIES V250DSP	Dec 22, 1995	Substantially Equivalent	Hitachi Medical Corp. of America
K952684	VERTEX EPIC MCD	Nov 24, 1995	Substantially Equivalent	Adac Laboratories
K953801	VARICAM	Nov 22, 1995	Substantially Equivalent	Elscint, Inc.
K952564	INSPECT/PROSPECT	Nov 22, 1995	Substantially Equivalent	Adac Laboratories
K953255	NUQUEST NUCLEAR MEDICINE COMPUTER	Oct 24, 1995	Substantially Equivalent	Sitco, Inc.
K953193	SCINTRON IV	Oct 24, 1995	Substantially Equivalent	Medical Imaging Electronics America, Inc.
K952674	TRANSACT: ATTENUATION CORRECTION SYSTEM FOR THE APEX CARDIAL GAMMA CAMERA	Sep 26, 1995	Substantially Equivalent	Elscint, Inc.
K952109	IP500 NUCLEAR GAMMA CAMERA SYSTEM	Aug 23, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K951144	PHOENIX PLUS & BASE NUCLEAR MEDICINE SINGLE DETECTOR SYSTEMS	Jul 03, 1995	Substantially Equivalent	GE Medical Systems
K943596	VANTAGE, FOR ADAC GAMMA CAMERAS	Apr 26, 1995	Substantially Equivalent	Adac Laboratories
K945721	PENN-PET SCANNER	Apr 07, 1995	Substantially Equivalent	Ugm Medical Systems, Inc.
K945652	ATTENUATION CORRECTION	Mar 31, 1995	Substantially Equivalent	GE Medical Systems
K946334	GALEN	Mar 23, 1995	Substantially Equivalent	Medimage, Inc.
K945261	PRISM 1500XP NUCLEAR GAMMA CAMERA SYSTEM	Mar 21, 1995	Substantially Equivalent	Ohio Imaging, Inc.
K942145	NON-UNIFORM ATTENUATION CORRECTION SYSTEM	Feb 22, 1995	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K942837	DST-XL	Jan 05, 1995	Substantially Equivalent	Sopha Medical Systems, Inc.
K944720	COMPUTER, DIAGNOSTIC, PRE-PROGRAMMED, SINGLE FUNCTION	Dec 23, 1994	Substantially Equivalent	Nuccardiac Software, Inc.
K941223	ADVANCE ANALYSIS SOFTWARE	Nov 29, 1994	Substantially Equivalent	General Electric Co.
K940487	ISOCAM II (DUAL HEAD GAMMA CAMERA)	Sep 30, 1994	Substantially Equivalent	Independent Scintilation Imaging Systems, Inc.
K942146	PHOENIX NUCLEAR MEDICINE PROCESSING COMPUTER	Sep 23, 1994	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K936001	PATLAK & FDG AUTORADIOGRAPHIC	Sep 23, 1994	Substantially Equivalent	GE Medical Systems
K942860	VISIONLINK DICOM MODULE	Sep 16, 1994	Substantially Equivalent	Evergreen Technologies, Inc.
K942363	CEQUAL-QUANTITATIVE ANALYSIS	Sep 16, 1994	Substantially Equivalent	Nuccardiac Software, Inc.
K942116	SNAC (SIEMENS NUCLEAR ACQUISITION COMPUTER)	Jul 29, 1994	Substantially Equivalent	Siemens Corp.
K934722	PRISM 3000 NUCLEAR GAMMA CAMERA SYSTEM MODIFICATION	May 13, 1994	Substantially Equivalent	Ohio Imaging, Inc.
K940236	QUANTITATIVE HEART	May 03, 1994	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K940300	MAGELLAN	Mar 29, 1994	Substantially Equivalent	GE Medical Systems
K940478	ECAT PRT	Mar 22, 1994	Substantially Equivalent	Cti Pet Systems, Inc.
K935318	SUMMIT NUCLEAR VISION FX 20 SERIES GAMMA CAMERA SYSTEMS	Feb 25, 1994	Substantially Equivalent	Summit Nuclear
K933321	DELTAMANAGER	Nov 03, 1993	Substantially Equivalent	Medimage, Inc.
K933446	PICTURE ARCHIVING & COMMUNICATIONS SYSTEMS(PACS)	Nov 01, 1993	Substantially Equivalent	Sudbury Systems, Inc.
K933372	VISIONLINK INTERFILE CONVERSION SOFTWARE	Nov 01, 1993	Substantially Equivalent	Evergreen Technologies, Inc.
K932745	C-EQUAL(CEDERS-EMORY QUANTITIVE ANALYSIS)	Aug 05, 1993	Substantially Equivalent	Adac Laboratories
K931297	GCA-7200A	Jul 27, 1993	Substantially Equivalent	Toshiba America Medical Systems, In.C
K926206	POSICAM-HZ & POSICAM-HZL	Jul 08, 1993	Substantially Equivalent	Positron
K931193	SIM-400 SYSTEM	Jun 21, 1993	Substantially Equivalent	Scinticor, Inc.
K930428	PENN-PET SCANNER	Jun 08, 1993	Substantially Equivalent	Ugm Medical Systems, Inc.
K926133	CORT-EX	Jun 08, 1993	Substantially Equivalent	General Electric Co.
K925330	SYSTEM, TOMOGRAPHIC, NUCLEAR	Jan 28, 1993	Substantially Equivalent	Rjl Associates, LLC
K925186	EQUILIBRIUM RADIONUCLIDE ANGIOCARDIORAPHY ANALYSIS	Jan 12, 1993	Substantially Equivalent	Strichman Medical Equipment, Inc.
K922303	M-LINK	Dec 11, 1992	Substantially Equivalent	Medimage, Inc.
K924877	OPTITRACK	Dec 07, 1992	Substantially Equivalent	Adac Laboratories
K924498	MAXXUS	Dec 03, 1992	Substantially Equivalent	GE Medical Systems
K923736	GAMMA 600T	Oct 16, 1992	Substantially Equivalent	Strichman Medical Equipment, Inc.
K923309	ARGUS PET SYSTEM	Sep 29, 1992	Substantially Equivalent	GE Medical Systems
K922427	SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM	Sep 29, 1992	Substantially Equivalent	Summit Nuclear
K922426	SUMMIT NUCLEAR VISION T-22 GAMMA CAMERA SYSTEM	Sep 28, 1992	Substantially Equivalent	Summit Nuclear
K923345	BIAD NEW DETECTOR OPTION	Sep 10, 1992	Substantially Equivalent	Trionix Research Laboratory, Inc.
K923151	CARDIAC TRIAD NEW DETECTOR OPTION	Sep 10, 1992	Substantially Equivalent	Trionix Research Laboratory, Inc.
K923044	MONAD NUCLEAR IMAGING SYSTEM	Aug 27, 1992	Substantially Equivalent	Trionix Research Laboratory, Inc.
K922373	MULTISPECT(TM) 2 DUAL DETECTOR CAMERA SYSTEM	Aug 17, 1992	Substantially Equivalent	Siemens Gammasonics, Inc.
K922372	MULTISPECT(TM) 3 TRIPLE DETECTOR CAMERA SYSTEM	Aug 17, 1992	Substantially Equivalent	Siemens Gammasonics, Inc.
K921777	CARDIAC FIRST PASS ANALYSIS	Aug 12, 1992	Substantially Equivalent	GE Medical Systems
K922671	CEDARS SINAI QUANTITATIVE THALLIUM 201 ANALYSIS	Aug 11, 1992	Substantially Equivalent	Nuccardiac Software, Inc.
K920958	SUMMIT NUCLEAR VISION NEUROSPECT	Aug 07, 1992	Substantially Equivalent	Summit Nuclear
K922080	GENESYS II	Jul 17, 1992	Substantially Equivalent	Adac Laboratories
K914267	GE 4096 PLUS & GE 2048	Jul 16, 1992	Substantially Equivalent	GE Medical Systems
K922313	P-LINK	Jul 10, 1992	Substantially Equivalent	Virtual Imaging
K921008	VECTOR SERIES	Apr 27, 1992	Substantially Equivalent	Sopha Medical Systems, Inc.
K920776	CARDIAC TRIAD NUCLEAR IMAGING SYSTEM	Apr 27, 1992	Substantially Equivalent	Trionix Research Laboratory, Inc.
K920624	ECAT EXACT HR MODEL 961	Apr 27, 1992	Substantially Equivalent	Cti Pet Systems, Inc.
K915470	OPTIMA NUCLEAR TOMOGRAPHY STYSTEM	Apr 16, 1992	Substantially Equivalent	General Electric Co.
K915644	CEDARS-SINAI QUANTITATIVE THALLIUM-201 ANALYSIS	Feb 27, 1992	Substantially Equivalent	Nuccardiac Software, Inc.
K914807	APEX HELIX - A	Feb 27, 1992	Substantially Equivalent	Elscint, Inc.
K913641	SOPHY NXT	Dec 17, 1991	Substantially Equivalent	Sopha Medical Systems, Inc.
K914296	CEQUAL(TM) QUANITATIVE ANALYSIS CARDIOLITE(R) SPEC	Nov 27, 1991	Substantially Equivalent	Nuccardiac Software, Inc.
K913637	ECAT SCANNER (MODEL 921)	Nov 27, 1991	Substantially Equivalent	Cti Pet Systems, Inc.
K914527	CEQUAL(TM)	Nov 22, 1991	Substantially Equivalent	General Electric Co.
K914179	CARDIOFOCAL COLLIMATOR	Oct 30, 1991	Substantially Equivalent	Siemens Gammasonics, Inc.
K912573	VISION (NUCLEAR MEDICINE COMPUTER)	Oct 28, 1991	Substantially Equivalent	Summit Nuclear
K913630	MULTISPECT 2 DUAL DETECTOR CAMERA SYSTEM	Oct 23, 1991	Substantially Equivalent	Siemens Gammasonics, Inc.
K913471	CIRRUS GAMMA CAMERA	Oct 23, 1991	Substantially Equivalent	Adac Laboratories
K912177	VISIONPRO	Sep 06, 1991	Substantially Equivalent	Trionix Research Laboratory, Inc.
K912176	ACQUPRO	Sep 06, 1991	Substantially Equivalent	Trionix Research Laboratory, Inc.
K911290	EAGLE NUCLEAR IMAGING SYSTEM	Aug 19, 1991	Substantially Equivalent	Trionix Research Laboratory, Inc.
K911078	MULTISPECT 3 TRIPLE DETECTOR CAMERA SYSTEM	Jun 17, 1991	Substantially Equivalent	Siemens Gammasonics, Inc.
K910048	ECAT SCANNER	May 17, 1991	Substantially Equivalent	Cti Pet Systems, Inc.
K911275	POSICAM SYSTEM MODEL 6.5 POSICAM-HZ SYSTEM	May 09, 1991	Substantially Equivalent	Positron
K896151	EMISSION TOMOGRAPHY CAROUSEL	Apr 16, 1991	Substantially Equivalent	Atf Consolidated
K900892	MICRODELTA, GATED SINGLE PHOTON (SPECT) PACKAGE	May 02, 1990	Substantially Equivalent	Siemens Gammasonics, Inc.
K901019	DIACAM GAMMA CAMERA SYSTEM	Apr 04, 1990	Substantially Equivalent	Siemens Gammasonics, Inc.
K896458	ASPECT GAMMA CAMERA	Dec 22, 1989	Substantially Equivalent	Digital Scintigraphics, Inc.
K894056	POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W	Nov 15, 1989	Substantially Equivalent	Shimadzu Medical Systems
K894998	MODIFIED POSICAM SYSTEM MODEL 6.5	Nov 02, 1989	Substantially Equivalent	Positron
K892358	PEGASYS NUCLEAR MEDICINE IMAGING COMPUTER	Aug 23, 1989	Substantially Equivalent	Adac Laboratories
K892875	BIAD NUCLEAR IMAGING SYSTEM	Jul 20, 1989	Substantially Equivalent	Trionix Research Laboratory, Inc.
K891266	NEUROFOCAL COLLIMATOR	Apr 17, 1989	Substantially Equivalent	Siemens Gammasonics, Inc.
K890100	PENN-PET SCANNER	Apr 13, 1989	Substantially Equivalent	Ugm Medical Systems, Inc.
K884349	ADAC VIEWPOINT (ADDITIONAL SOFTWARE)	Dec 22, 1988	Substantially Equivalent	Adac Laboratories
K875378	SINGLE PHOTON SET 031 & AZ-701-NTS-SP EMISSION	Nov 16, 1988	Substantially Equivalent	Shimadzu Precision Instruments, Inc.
K873775	TRIAD NUCLEAR IMAGING SYSTEM	Jan 19, 1988	Substantially Equivalent	Trionix Research Laboratory, Inc.
K862511	TOMOMATIC 232	Jul 10, 1987	Substantially Equivalent	Medimatic
K861252	NON-CIRCULAR ORBITING OPTION	Apr 16, 1986	Substantially Equivalent	Siemens Gammasonics, Inc.
K850416	TOMOMATIC 564	Sep 20, 1985	Substantially Equivalent	M.I.D., Inc.
K852239	POSICAM TM(MODEL 3.2,4.3,6.5)	Sep 03, 1985	Substantially Equivalent	Position Corp.
K843366	SUPERPETT	Nov 21, 1984	Substantially Equivalent	Scanditronix, Inc.
K810589	NEURO-ECAT	Apr 10, 1981	Substantially Equivalent	Eg&G Ortec, Inc.
K802801	GE RT/PLAN MAGNETIC TAPE DRIVE OPTION	Jan 15, 1981	Substantially Equivalent	General Electric Co.
K791055	ADAC TOMOGRAPHY OPTION	Sep 17, 1979	Substantially Equivalent	Adac Laboratories
K790169	TOMOGRAPHIC PROGRAMS	Feb 15, 1979	Substantially Equivalent	Cmsi
K781753	TOMOGSCANNER 2	Nov 03, 1978	Substantially Equivalent	Tomogscanner OK , Ltd.
K770220	RADIONUCLIDE COMPUTED TOMOGRAPHY SYS.	Feb 28, 1977	Substantially Equivalent	G.D. Searle and Co.