Product Code: LNH FDA class 2 21 CFR 892.1000

System, Nuclear Magnetic Resonance Imaging

Radiology

System, Nuclear Magnetic Resonance Imaging is a magnetic resonance imaging (MRI) system that uses strong magnetic fields and radiofrequency pulses to generate detailed cross-sectional images of the body's internal structures, widely used in diagnostic radiology for evaluating soft tissue, neurological, musculoskeletal, cardiovascular, and oncological conditions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LNH, regulated under 21 CFR 892.1000, within the Radiology medical specialty. This device is eligible for third-party 510(k) review.

View on FDA

510(k)s

1072

FEI Numbers

152

Registration Numbers

152

Unique Applicants

245

Years Active

Basic Information

Product Code: LNH
Device Class: FDA class 2
Regulation Number: 892.1000
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 1072 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K251808	Achieva; Intera; Ingenia 1.5T; Ingenia 3.0T; Ingenia 1.5T CX; Ingenia 3.0T CX; Ingenia Elition S; Ingenia Elition X; Ingenia Ambition S; Ingenia Ambition X; and MR 5300 MR Systems	Jul 11, 2025	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K250443	MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.Mobile	Jun 16, 2025	Substantially Equivalent	Siemens Healthcare GmbH
K250436	MAGNETOM Flow.Ace; MAGNETOM Flow.Plus	Jun 16, 2025	Substantially Equivalent	Siemens Shenzhen Magnetic Resonance Ltd.
K243667	Sonic DL	Jun 05, 2025	Substantially Equivalent	GE Medical Systems, LLC
K251397	Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, BlueSeal, MR 5300 and MR 7700 MR System	Jun 04, 2025	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K250236	Swoop® Portable MR Imaging® System (V2)	May 30, 2025	Substantially Equivalent	Hyperfine, Inc.
K251276	Swoop® Portable MR Imaging® System	May 21, 2025	Substantially Equivalent	Hyperfine, Inc.
K243122	uMR Omega	May 21, 2025	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K250379	SIGNA Prime Elite	Mar 17, 2025	Substantially Equivalent	GE Medical Systems, LLC
K242006	SureWave Elastography (Q7000225)	Feb 12, 2025	Substantially Equivalent	Quality Electrodynamics, LLC
K242825	Prenuvo Body Composition	Jan 17, 2025	Substantially Equivalent	Prenuvo
K243335	Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR	Jan 07, 2025	Substantially Equivalent	Canon Medical Systems Corporation
K242573	NIDO Baby Magnetic Resonance Imaging System	Dec 23, 2024	Substantially Equivalent	Jiangsu LiCi Medical Device Co., Ltd.
K242524	SyMRI	Dec 06, 2024	Substantially Equivalent	SyntheticMR AB (Publ.)
K242258	MROpen Evo (03-2000-00); MROpen Evo (03-4000-00)	Nov 26, 2024	Substantially Equivalent	ASG Superconductors S.P.A.
K241242	SIGNA MAGNUS	Oct 17, 2024	Substantially Equivalent	GE Medical Systems, LLC
K241925	VitruvianScan (v1.0)	Oct 02, 2024	Substantially Equivalent	Perspectum Ltd
K241331	MuscleView	Oct 01, 2024	Substantially Equivalent	Springbok, Inc.
K241607	MyoStrain (6.0)	Aug 26, 2024	Substantially Equivalent	Myocardial Solutions, Inc.
K241496	Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR	Aug 20, 2024	Substantially Equivalent	Canon Medical Systems Corporation
K241429	ECHELON Synergy MRI System	Aug 13, 2024	Substantially Equivalent	FUJIFILM Healthcare Corporation
K231133	neo315	Jul 22, 2024	Substantially Equivalent	Neoscan Solution GmbH
K240944	Swoop® Portable MR Imaging® System	Jul 16, 2024	Substantially Equivalent	Hyperfine, Inc.
K241133	Magnifico Open (100009900); Magnifico MSK ( 100009910)	Jun 26, 2024	Substantially Equivalent	Esaote S.p.A.
K233629	APERTO Lucent MRI System	May 10, 2024	Substantially Equivalent	FUJIFILM Healthcare Americas Corporation
K233687	ECHELON Synergy V10.0	May 03, 2024	Substantially Equivalent	Fujifilm Healthcare Americas Corporation
K233673	uMR Jupiter	Apr 26, 2024	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd
K240571	OASIS MRI System	Apr 12, 2024	Substantially Equivalent	Fujifilm Healthcare Corporation
K240238	Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 with AiCE Reconstruction Processing Unit for MR	Apr 12, 2024	Substantially Equivalent	Canon Medical Systems Corporation
K240744	uMR 680	Apr 10, 2024	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K240608	MAGNETOM Viato.Mobile	Mar 29, 2024	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K233733	SyMRI	Mar 26, 2024	Substantially Equivalent	SyntheticMR AB (Publ)
K240540	uMR Omega	Mar 22, 2024	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K232322	MAGNETOM Terra; MAGNETOM Terra.X	Mar 22, 2024	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K232765	MAGNETOM Cima.X Fit	Feb 29, 2024	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K240157	InVision 1.5 Surgical Theatre	Feb 15, 2024	Substantially Equivalent	Deerfield Imaging, Inc.
K232644	neuro42 MRI System	Feb 08, 2024	Substantially Equivalent	Neuro42, Inc.
K233728	SIGNA Champion	Jan 19, 2024	Substantially Equivalent	GE Healthcare (Tianjin) Company Limited
K232535	MAGNETOM Sola; MAGNETOM Altea	Dec 22, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K231587	MAGNETOM Cima.X	Dec 18, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K232680	fMRI Hardware System	Dec 13, 2023	Substantially Equivalent	NordicNeuroLab AS
K232494	MAGNETOM Avanto fit; MAGNETOM Skyra fit	Nov 14, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K231617	MAGNETOM Free.Max; MAGNETOM Free.Star	Nov 09, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K232346	Digital Expert Access with Remote Scanning	Oct 27, 2023	Substantially Equivalent	GE Healthcare
K231560	MAGNETOM Vida; MAGNETOM Lumina; MAGNETOM Aera; MAGNETOM Skyra; MAGNETOM Prisma; MAGNETOM Prisma fit	Oct 23, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K232981	Synq Software Version 1.3	Oct 11, 2023	Substantially Equivalent	Synaptive Medical Inc.
K232760	Swoop® Portable MR Imaging System®	Oct 06, 2023	Substantially Equivalent	Hyperfine, Inc.
K230187	Terran NM-101	Sep 29, 2023	Substantially Equivalent	Terran Biosciences, Inc.
K232482	MAGNETOM Viato.Mobile	Sep 06, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K232361	Promaxo MRI System II	Sep 05, 2023	Substantially Equivalent	Promaxo, Inc.
K230355	Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR	Aug 30, 2023	Substantially Equivalent	Canon Medical Systems Corporation
K232030	Ingenia Elition R5.7.1 SP4 MR Systems	Aug 02, 2023	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K223426	ECHELON Synergy MRI system	Jul 13, 2023	Substantially Equivalent	FUJIFILM Healthcare Corporation
K231459	HepaFatSmart (V2.0.0)	Jun 20, 2023	Substantially Equivalent	Resonance Health Analysis Services Pty Ltd
K223523	Sonic DL	May 30, 2023	Substantially Equivalent	GE Medical Systems,LLC (GE Healthcare)
K230152	uMR Omega	May 23, 2023	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K230758	uMR 570	May 18, 2023	Substantially Equivalent	Shanghai United Imaging Healthcare Co.,Ltd.
K230972	Ingenia Elition and MR 7700 MR Systems	Apr 28, 2023	Substantially Equivalent	Philips Medical Systems, Nederland B.V.
K223458	Ingenia, Ingenia CX, Ingenia Elition, Ingenia Ambition, MR 5300 and MR 7700 MR Systems	Apr 06, 2023	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K223343	MAGNETOM Amira; MAGNETOM Sempra	Mar 28, 2023	Substantially Equivalent	Siemens Medical Solutions USA Inc.
K223875	MOBINEURO Alita Intraoperative MRI System	Mar 20, 2023	Substantially Equivalent	Sino Canada Health Engineering Research Institute (Hefei)
K223203	1.5T 24E Posterior Array	Mar 02, 2023	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K213805	MAGNETOM Vida	Feb 24, 2023	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K230208	Swoop® Portable MR Imaging System	Feb 22, 2023	Substantially Equivalent	Hyperfine, Inc.
K222259	NEONA 1.5T MRI System	Feb 21, 2023	Substantially Equivalent	Time Medical Limited
K222755	uMR 680	Feb 16, 2023	Substantially Equivalent	Shanghai United Imaging Intelligence Co., Ltd.
K223439	SIGNA Victor	Feb 13, 2023	Substantially Equivalent	GE Healthcare (Tianjin) Company Limited
K221619	ECHELON Oval V6.2 MRI System	Jan 26, 2023	Substantially Equivalent	Fujifilm Healthcare Corporation
K223442	MR 5300 and MR 7700 R11 MR Systems	Dec 23, 2022	Substantially Equivalent	Philips Medical Systems Nederlands B.V.
K223247	Swoop Portable MR Imaging System	Dec 06, 2022	Substantially Equivalent	Hyperfine, Inc.
K223079	Stage	Oct 28, 2022	Substantially Equivalent	SpinTech, Inc.
K220332	uMR Omega with uWS-MR-MRS	Oct 27, 2022	Substantially Equivalent	Shanghai United Imaging Healthcare Co.,Ltd.
K222968	Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR	Oct 25, 2022	Substantially Equivalent	Canon Medical Systems Corporation
K221733	MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit	Sep 13, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K213960	LiverMultiScan v5 (LMSv5)	Sep 06, 2022	Substantially Equivalent	Perspectum
K222387	Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR	Aug 31, 2022	Substantially Equivalent	Canon Medical Systems Corporation
K221785	TCL3 Motion Tracking System	Aug 29, 2022	Substantially Equivalent	TracInnovations A/S
K221923	Swoop Portable MR Imaging System	Jul 28, 2022	Substantially Equivalent	Hyperfine, Inc.
K203279	Veuron-Brain-mN1	Jul 12, 2022	Substantially Equivalent	Heuron Co., Ltd.
K221025	i_ Field 1.5T Superconducting Magnetic Resonance Imaging System	Jul 01, 2022	Substantially Equivalent	MRI Division,Beijing Wandong Medical Technology Co.,Ltd.
K220575	MAGNETOM Free.Max, MAGNETOM Free.Star	Jun 24, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K221393	Swoop Portable MR Imaging System	Jun 10, 2022	Substantially Equivalent	Hyperfine, Inc.
K213717	AIR Recon DL	Jun 08, 2022	Substantially Equivalent	GE Medical Systems,LLC (GE Healthcare)
K213583	Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems	May 16, 2022	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K220589	MAGNETOM Skyra Fit	May 13, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K220939	MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A	Apr 29, 2022	Substantially Equivalent	Siemens Medical Solutions USA Inc.
K220192	Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit for MR	Apr 08, 2022	Substantially Equivalent	Canon Medical Systems Corporation
K220335	Vantage Fortian/Orian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR	Apr 05, 2022	Substantially Equivalent	Canon Medical Systems Corporation
K220151	MAGNETOM Avanto Fit	Apr 01, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K220425	MAGNETOM Vida, MAGNETOM Sola	Mar 11, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K220018	MR Elastography; MZEK-001A	Mar 03, 2022	Substantially Equivalent	Canon Medical Systems Corporation
K213516	Ingenia 3.0T, Ingenia 3.0T CX, Ingenia Elition and MR 7700 with Distributed Multi Nudclei	Mar 03, 2022	Substantially Equivalent	Philips Medical Systems Nederland, B.V.
K213693	MAGNETOM Vida with syngo MR XA50A	Feb 25, 2022	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K213603	SIGNA Artist Evo	Feb 11, 2022	Substantially Equivalent	GE Healthcare(Tianjin) Company Limited
K212419	Magnifico Open, Magnifico MSK	Feb 04, 2022	Substantially Equivalent	Esaote S.p.A.
K212271	smart-sync	Feb 04, 2022	Substantially Equivalent	northh medical GmbH
K213668	SIGNA Hero	Jan 20, 2022	Substantially Equivalent	GE Healthcare (GE Medical Systems, LLC)
K211980	SIGNA Prime	Jan 16, 2022	Substantially Equivalent	GE Healthcare (Tianjin) Company Limited
K213305	Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR	Dec 01, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K211983	AMRA Profiler	Nov 24, 2021	Substantially Equivalent	AMRA Medical AB
K212673	MR 5300	Nov 19, 2021	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K212456	Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System	Nov 17, 2021	Substantially Equivalent	Hyperfine, Inc.
K203372	SyMRI	Nov 03, 2021	Substantially Equivalent	SyntheticMR AB
K211406	OASIS MRI System	Oct 07, 2021	Substantially Equivalent	Hitachi Healthcare Americas
K212233	RTHawk, HeartVista Cardiac Package	Oct 05, 2021	Substantially Equivalent	HeartVista, Inc.
K212367	IMRIS iMRI 3T V	Aug 23, 2021	Substantially Equivalent	Deerfield Imaging, Inc.
K212056	Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR	Aug 04, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K211633	Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR	Jul 22, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K210415	QSM software, QSMetric	Jul 22, 2021	Substantially Equivalent	Medimagemetric LLC
K211818	Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System	Jul 07, 2021	Substantially Equivalent	Hyperfine, Inc.
K210611	MAGNETOM Free.Max	Jul 01, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K210843	STAGE	Jun 29, 2021	Substantially Equivalent	SpinTech, Inc.
K211037	Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR	May 17, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K211118	SIGNA 7.0T	May 13, 2021	Substantially Equivalent	GE Medical Systems, LLC
K203451	TCL3 Motion Tracking System	Apr 28, 2021	Substantially Equivalent	Tracinnovations ApS
K210340	Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR	Apr 01, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K203443	MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, MAGNETOM Altea	Mar 31, 2021	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K210164	Vantage Elan 1.5T, MRT-2020, V6.0	Mar 10, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K203323	Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR	Mar 04, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K202518	Promaxo MRI System	Mar 03, 2021	Substantially Equivalent	Promaxo, Inc.
K203653	MRI PPG Patient Cable	Mar 02, 2021	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K203553	Vantage Galan 3T, MRT-3020, V7.0 with AiCE Reconstruction Processing Unit for MR	Feb 02, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K192650	i_Space 1.5T Superconducting Magnetic Resonance Imaging System	Jan 29, 2021	Substantially Equivalent	MRI Division, Beijing Wandong Medical Technology Co., Ltd.
K202767	Vantage Orian 1.5T, MRT-1550, V6.0	Jan 15, 2021	Substantially Equivalent	Canon Medical Systems Corporation
K203280	Hepatica v1 (Hepatica v1.0.0)	Jan 12, 2021	Substantially Equivalent	Perspectum Ltd.
K201039	HepaFat-AI	Dec 07, 2020	Substantially Equivalent	Resonance Health Analysis Services Pty Ltd
K203053	Vantage Orian 1.5T, MRT-1550, V7.0 with AiCE Reconstruction Processing Unit for MR	Dec 02, 2020	Substantially Equivalent	Canon Medical Systems Corporation
K202966	SIGNA Architect	Nov 13, 2020	Substantially Equivalent	GE Healthcare (GE Medical Systems, LLC)
K202030	OASIS MRI System	Oct 21, 2020	Substantially Equivalent	Hitachi Healthcare Americas
K201615	SIGNA 7.0T	Oct 15, 2020	Substantially Equivalent	GE Medical Systems, LLC
K202170	LiverMultiScan	Oct 02, 2020	Substantially Equivalent	Perspectum LTD
K202210	Vantage Orian 1.5T, MRT-1550, V6.0	Sep 22, 2020	Substantially Equivalent	Canon Medical Systems Corporation
K202014	Magnetom Aera, Magnetom Skyra, Magnetom Prisma/Prisma fit	Sep 08, 2020	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K202238	SIGNA Artist	Sep 04, 2020	Substantially Equivalent	GE Healthcare (Tianjin) Company Limited
K201141	FIRMM	Aug 26, 2020	Substantially Equivalent	Nous Imaging, Inc.
K201722	Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System	Aug 11, 2020	Substantially Equivalent	Hyperfine Research, Inc.
K201616	SyMRI	Jul 28, 2020	Substantially Equivalent	SyntheticMR AB
K193097	Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit for MR	Jul 14, 2020	Substantially Equivalent	Canon Medical Systems Corporation
K201389	Resoundant Acoustic Driver System	Jul 10, 2020	Substantially Equivalent	Resoundant Inc
K201540	uMR570	Jul 06, 2020	Substantially Equivalent	Shanghai United Imaging Healthcare Co.,Ltd.
K193021	Vantage Orian 1.5T, MRT-1550, V6.0	Jun 03, 2020	Substantially Equivalent	Canon Medical Systems Corporation
K193176	uMR 780	May 05, 2020	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd
K200327	Evry	Apr 29, 2020	Substantially Equivalent	Synaptive Medical Inc.
K200024	uMR 570	Apr 20, 2020	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K193282	SIGNA Premier	Apr 10, 2020	Substantially Equivalent	GE Healthcare (GE Medical Systems, LLC)
K193215	Achieva, Intera, Ingenia, Ingneia CX, Ingenia Elition, and Ingenia Ambition MR Systems	Apr 10, 2020	Substantially Equivalent	Philips Medical Systems Nederland BV
K193218	Innovision Audio	Apr 07, 2020	Substantially Equivalent	Innovere Medical Inc.
K192852	MRI ECG Patient Cable	Mar 28, 2020	Substantially Equivalent	Ivy Biomedical Systems, Inc.
K193200	uMR Omega	Mar 27, 2020	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K192924	MAGNETOM Vida, MAGNETOM Lumina, MAGNETOM Vida Fit	Mar 11, 2020	Substantially Equivalent	Siemens Medical Solutions USA Inc.
K192574	Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR	Mar 09, 2020	Substantially Equivalent	Canon Medical Systems Corporation
K192506	Vantage Galan 3T, MRT-3020, V6.0	Mar 02, 2020	Substantially Equivalent	Canon Medical Systems Corporation
K192496	Magnetom Sola, Magnetom Altea and Magnetom Sola Fit	Feb 28, 2020	Substantially Equivalent	Siemens Medical Solutions USA Inc.
K192851	OASIS MRI System	Feb 21, 2020	Substantially Equivalent	Hitachi Healthcare Americas
K192002	Lucy Point-of-Care Magnetic Resonance Imaging Device	Feb 06, 2020	Substantially Equivalent	Hyperfine Research, Inc.
K193324	Motion Correction System	Feb 04, 2020	Substantially Equivalent	KinetiCor, Inc.
K193102	MRIaudio PREM System with MRIview	Jan 06, 2020	Substantially Equivalent	MRIaudio, Inc.
K193116	MRopen EVO	Dec 20, 2019	Substantially Equivalent	ASG Superconductors S.p.A.
K191032	fMRI Hardware System	Nov 27, 2019	Substantially Equivalent	NordicNeurolab AS
K192690	Upgrade Kit MR GUI PRO, MrJ 3300 Plus	Oct 24, 2019	Substantially Equivalent	ASG Superconductors S.p.A.
K183274	RTHawk, HeartVista Cardiac Package	Oct 18, 2019	Substantially Equivalent	HeartVista, Inc.
K192426	Signa Voyager, Signa Voyager Quantum	Oct 01, 2019	Substantially Equivalent	GE Healthcare(Tianjin) Company Limited
K191662	Vantage Orian 1.5T, MRT-1550, V4.5	Jul 23, 2019	Substantially Equivalent	Canon Medical Systems Corporation
K191050	MAGNETOM Aera and MAGNETOM Skyra with Software syngo MR E11E with Ischemic Heart Disease (IHD) Workflow	Jul 12, 2019	Substantially Equivalent	Siemens Medical Solutions, USA Inc.
K190524	MRopen 0.5 T	Jul 01, 2019	Substantially Equivalent	ASG Superconductors S.p.A.
K190017	LiverMultiScan (LMSv3)	Jun 27, 2019	Substantially Equivalent	Perspectum Diagnostics Ltd
K191128	Vantage Titan 3T, MRT-3010, V2.5	Jun 26, 2019	Substantially Equivalent	Canon Medical Systems Corporation
K191036	SyMRI	Jun 13, 2019	Substantially Equivalent	SyntheticMR AB
K190461	Achieva 1.5T, 3.0T and Intera 1.5T MR Systems	Jun 04, 2019	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K190757	MAGNETOM Avanto Fit	May 31, 2019	Substantially Equivalent	Siemens Medical Solution USA, Inc.
K191157	uMR 780, uMR 790	May 29, 2019	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K183657	Vantage Galan 3T, MRT-3020/A9, V5.0	Mar 15, 2019	Substantially Equivalent	Canon Medical Systems Corporation
K183621	EMMA 1.5T MRI System	Feb 22, 2019	Substantially Equivalent	Time Medical Limited
K190138	MAGNETOM Aera	Feb 15, 2019	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K183222	MAGNETOM Terra	Feb 15, 2019	Substantially Equivalent	Siemens Medical Solutions USA Inc.
K183221	MAGNETOM Amira, MAGNETOM Sempra	Feb 14, 2019	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K183063	Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems	Feb 14, 2019	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K182756	MyoStrain 5.1	Feb 14, 2019	Substantially Equivalent	Myocardial Solutions
K183244	MAGNETOM Lumina	Jan 24, 2019	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K183685	O-Scan	Jan 22, 2019	Substantially Equivalent	Esaote S.p.A
K183254	Magnetom Vida	Jan 18, 2019	Substantially Equivalent	Siemens Medical Solutions, USA, Inc.
K183231	SIGNA Premier	Jan 18, 2019	Substantially Equivalent	GE Medical Systems, LLC
K183137	uMR 580, uMR 588	Jan 11, 2019	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K173749	AMRA Profiler	Dec 06, 2018	Substantially Equivalent	AMRA Medical AB
K181613	MAGNETOM Avanto, MAGNETOM Verio with software syngo MR E11D	Nov 06, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K182299	MAGNETOM Aera	Oct 26, 2018	Substantially Equivalent	Siemens Medical Solutions USA Inc.
K182282	Vantage Orian 1.5T, MRT-1550, V4.5	Oct 19, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K181433	MAGNETOM Vida	Oct 19, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K182129	MAGNETOM Sola	Oct 12, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K181322	MAGNETOM Sola	Oct 05, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K181371	uMR 790	Oct 03, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co.,Ltd.
K181370	uMR 780	Oct 03, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K181593	Vantage Galan 3T, MRT-3020/A7, V5.0	Aug 13, 2018	Substantially Equivalent	Canon Medical Systems Corporation
K181479	Ingenia Ambition S and Ingenia Ambition X	Aug 03, 2018	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K173507	Prodiva 1.5T CX and Prodiva 1.5T CS R5.4	Jun 15, 2018	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.
K180100	MRIaudio PREM System	Jun 14, 2018	Substantially Equivalent	MRIaudio
K181093	SyMRI	Jun 12, 2018	Substantially Equivalent	SyntheticMR AB
K180926	uMR 560	Jun 06, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co.,Ltd.
K180925	uMR 570	Jun 06, 2018	Substantially Equivalent	Shanghai United Imaging Healthcare Co.,Ltd.
K173079	Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4	Apr 04, 2018	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K180592	G-scan Brio	Mar 30, 2018	Substantially Equivalent	Esaote S.p.A
K173617	MAGNETOM Vida with Compressed Sensing GRASP-VIBE	Mar 30, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K173451	Ingenia Elition S and Ingenia Elition X	Mar 20, 2018	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K171778	MR Wireless Gating System, Model WGS-100	Mar 14, 2018	Substantially Equivalent	Ivy Biomedical Systems, Inc
K173356	Ingenia Elition S and Ingenia Elition X R5.4	Mar 06, 2018	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K173224	SPIN-SWI	Feb 23, 2018	Substantially Equivalent	SpinTech, Inc.
K173409	Wireless Audio System	Feb 16, 2018	Substantially Equivalent	NeoCoil, LLC
K173592	MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit	Feb 13, 2018	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K173558	SyMRI	Jan 26, 2018	Substantially Equivalent	SyntheticMR AB
K173382	Vantage Galan 3T, V4.6	Jan 26, 2018	Substantially Equivalent	Toshiba Medical Systems Corporation
K172920	3D APT	Jan 22, 2018	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K172110	ECHELON OVAL V6.0A MRI System	Jan 11, 2018	Substantially Equivalent	Hitachi Healthcare Americas Corporation
K173600	MAGNETOM Amira	Dec 19, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K172685	LiverMultiScan	Nov 21, 2017	Substantially Equivalent	Perspectum Diagnostics Ltd
K172878	Vantage Titan 3T, MRT-3010/A7, M-Power GX	Nov 17, 2017	Substantially Equivalent	Toshiba Medical Systems Corporation, Japan
K170840	MAGNETOM Terra	Oct 12, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K162943	SyMRI	Aug 29, 2017	Substantially Equivalent	SyntheticMR AB
K171597	Vantage Elan 1.5T, V4.0	Jul 21, 2017	Substantially Equivalent	Toshiba Medical Systems Corporation
K170978	Embrace Neonatal MRI System	Jul 19, 2017	Substantially Equivalent	Aspect Imaging Ltd.
K171128	SIGNA Premier	Jul 14, 2017	Substantially Equivalent	GE Medical Systems, LLC
K170090	RTHawk, HeartVista Cardiac Package	Jul 14, 2017	Substantially Equivalent	HeartVista, Inc.
K170396	MAGNETOM Vida	Jun 14, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K170412	Vantage Titan 1.5T, MRT-1510, M-Power GX	Jun 07, 2017	Substantially Equivalent	Toshiba Medical Systems Corporation
K162722	HyperSense	Apr 20, 2017	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K163192	Comfort EC710	Apr 10, 2017	Substantially Equivalent	ALLTECH MEDICAL SYSTEMS AMERICA, INC.
K163331	Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist	Mar 17, 2017	Substantially Equivalent	GE Medical Systems, LLC
K163312	MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software	Jan 27, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K163211	MAGNETOM Sempra with syngo MR E11S	Jan 27, 2017	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K163116	Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3	Jan 06, 2017	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K162931	Ingenia 1.5T CX and Ingenia 3.0T CX R5.3	Jan 06, 2017	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K162940	MultiBand SENSE	Dec 30, 2016	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K162183	Vantage Galan 3T, MRT-3020, V4.0	Nov 25, 2016	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION
K162102	MAGNETOM Avantofit, MAGNETOM Skyrafit	Nov 22, 2016	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS, INC.
K162403	HyperBand	Nov 18, 2016	Substantially Equivalent	GE Medical Systems, LLC
K161795	MAGNETOM ESSENZA	Nov 18, 2016	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K161973	G-scan Brio, S-scan	Oct 25, 2016	Substantially Equivalent	Esaote S.p.A.
K161567	SIGNA Voyager	Sep 01, 2016	Substantially Equivalent	GE HEALTHCARE
K161397	MAGiC	Aug 31, 2016	Substantially Equivalent	GE Medical Systems, LLC
K160632	Vantage Titan 1.5T, MRT-1510, V3.6 Software	Aug 23, 2016	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION
K161238	S-scan	Jul 08, 2016	Substantially Equivalent	Esaote S.p.A.
K153740	RTHawk, HeartVista Cardiac Package	Jun 30, 2016	Substantially Equivalent	HeartVista, Inc.
K160618	Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T	Jun 09, 2016	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K160152	Trillium Oval V 5.1 MRI System	May 20, 2016	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K153343	MAGNETOM Aera, MAGNETOM Skyra, MAGNETOM Prisma, MAGNETOM Prisma fit	Apr 15, 2016	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS, INC.
K153547	ECHELON Oval V 5.1 MRI System	Mar 31, 2016	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K153447	MAGNETOM Spectra	Mar 31, 2016	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K160621	SIGNAPioneer	Mar 29, 2016	Substantially Equivalent	GE HEALTHCARE
K153324	Ingenia 1.5T and Ingenia 1.5T S R5.2	Mar 22, 2016	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V.
K160185	Wrist 3	Mar 01, 2016	Substantially Equivalent	ASPECT IMAGING LTD
K153039	MRI Dynamic Analysis Plus	Jan 08, 2016	Substantially Equivalent	Esaote S.p.A.
K152283	MAGNETOM Amira	Dec 24, 2015	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K151074	Magnetic Reasonance Imaging System	Dec 22, 2015	Substantially Equivalent	JIANGSU MAGSPIN INSTRUMENT CO.,LTD
K153003	SIGNA Pioneer	Oct 27, 2015	Substantially Equivalent	GE HEALTHCARE
K152371	Vantage Titan 3T	Oct 23, 2015	Substantially Equivalent	Toshiba Medical Systems Corporation
K151466	MrOpen	Oct 15, 2015	Substantially Equivalent	Paramed S.r.l.
K151579	MAGNETOM Aera (24-channel), MAGNETOM Avanto fit, MAGNETOM Skyra fit, MAGNETOM Prisma, MAGNETOM Prisma fit	Sep 29, 2015	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K151668	S-scan	Sep 08, 2015	Substantially Equivalent	ESAOTE S.P.A.
K151015	ECHELON Oval V 5.0 MRI System	Jul 29, 2015	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K143345	SIGNA Pioneer	Jul 10, 2015	Substantially Equivalent	GE HEALTHCARE JAPAN CORPORATION
K143020	LiverMultiScan	Jun 23, 2015	Substantially Equivalent	MIRADA MEDICAL LTD.
K143606	MultiBand SENSE	May 08, 2015	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NETHRLANDS BV
K150427	Vantage Titan 1.5T, V3.1, MRT-1510	Apr 17, 2015	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION
K143253	O-MAR	Apr 09, 2015	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V.
K143008	Vantage Titan 3T	Apr 09, 2015	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION
K142421	G-scan Brio	Apr 09, 2015	Substantially Equivalent	ESAOTE, S.P.A.
K143128	mDIXON XD	Mar 20, 2015	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
K142734	TRILLIUM Oval MR System	Mar 02, 2015	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K143251	SIGNA Creator, SIGNA Explorer	Feb 04, 2015	Substantially Equivalent	GE HEALTHCARE (GE MEDICAL SYSTEMS,LLC)
K141945	ECHOSTAR COMFORT 1.5T MRI	Feb 03, 2015	Substantially Equivalent	ALLTECH MEDICAL SYSTEMS AMERICA, INC.
K142997	RTHawk, HeartVista Workstation with RTHawk	Dec 17, 2014	Substantially Equivalent	HEARTVISTA, INC.
K142361	Discovery MR750 3.0T	Dec 05, 2014	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K141977	MAGNETOM AERA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH SOFTWARE SYNGO MR E11A, MAGNETOM SKYRA WITH 24 RF CHANNEL	Nov 19, 2014	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K131737	SUPERNOVA C5 MRI SYSTEM	Oct 23, 2014	Substantially Equivalent	LIAONING KAMPO MEDICAL SYSTEM CO., LTD.
K142515	MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra	Oct 08, 2014	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K142085	DISCOVERY MR750 3.0T ,DISCOVERY MR450 1.5T, DISCOVERY MR750 3.0T,OPTIMA MR450W 1.5T	Sep 26, 2014	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K141472	VANTAGE ELAN	Sep 19, 2014	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS INC
K140956	LCD MONITOR	Aug 07, 2014	Substantially Equivalent	NORDICNEUROLAB
K133670	HEADPHONES, PATIENT ALERT, STANDALONE INTERFACE	Jul 24, 2014	Substantially Equivalent	NEOCOIL, LLC
K133848	RTHAWK, RTHAWK, OR HEARTVISTA WORKSTATION WITH RTHAWK	Jun 25, 2014	Substantially Equivalent	HEARTVISTA, INC.
K140666	MR ELASTOGRAPHY	Jun 13, 2014	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K132381	CLEARMRI HELIOS-RG8 COIL ACCESSORY KIT	Apr 04, 2014	Substantially Equivalent	CLEARMRI SOLUTIONS, INC.
K140253	MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE	Mar 20, 2014	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K131896	SUPERVAN 1.5T MAGNETIC RESONANCE IMAGING SYSTEM	Feb 28, 2014	Substantially Equivalent	SUZHOU ANKE MEDICAL SYSTEM CO., LTD
K133526	MDIXON-QUANT	Feb 12, 2014	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K133692	IMRI 1.5T AND IMRI 3T S	Feb 10, 2014	Substantially Equivalent	IMRIS, INC.
K130692	M2 WRIST 2 MRI SYSTEM	Jan 14, 2014	Substantially Equivalent	ASPECT IMAGING LTD
K133490	G-SCAN BRIO	Dec 30, 2013	Substantially Equivalent	ESAOTE S.P.A.
K131996	S-SCAN	Dec 13, 2013	Substantially Equivalent	ESAOTE, S.P.A.
K122035	HEPAFAT SCAN	Dec 13, 2013	Substantially Equivalent	RESONANCE HEALTH ANALYSIS SERVICES PTY LTD
K133435	MAGNETOM AERA AND SKYRA WITH SOFTWARE MR D13A	Dec 12, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K132119	MAGNETOM PRISMA, MAGNETOM PRISMA FIT	Nov 22, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K132951	MAGNETOM AERA	Nov 15, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K132376	DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T	Nov 15, 2013	Substantially Equivalent	GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
K132831	QUIET/SILENT SCANNING SUITE	Nov 01, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K132160	VANTAGE TITAN 3T	Oct 16, 2013	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION
K131241	SWIP	Aug 30, 2013	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K130658	ELIXBO PM545	Jul 19, 2013	Substantially Equivalent	XBO MEDICAL SYSTEMS CO., LTD
K130115	DISCOVERY MR750W 3.0T	May 23, 2013	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K130885	MAGNETOM AVANTO-FIT, MAGNETOM SKYRA-FIT	May 17, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K123510	MAGNETOM SKYRA	May 17, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K123522	OPTIMA MR450W	Mar 13, 2013	Substantially Equivalent	GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC)
K130262	MAGNETOM ESSENZA WITH SYNGO MR D14	Mar 01, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K123938	SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN	Feb 12, 2013	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K120701	M2 WRIST MRI SYSTEM	Feb 07, 2013	Substantially Equivalent	ASPECT IMAGING LTD
K123417	BRIVO MR355, OPTIMA MR360	Jan 17, 2013	Substantially Equivalent	GE HANGWEI MEDICAL SYSTEMS CO., LTD.
K122613	VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/US	Dec 13, 2012	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K113394	MAVRIC SL	Dec 11, 2012	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K122034	MRJ 3300	Dec 06, 2012	Substantially Equivalent	PARAMED SRL
K123068	OPTIMA MR 430S	Nov 13, 2012	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K121434	SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO	Nov 05, 2012	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS, INC.
K122026	PRISM ACQUIRE PRISM PROCESS PRISM VIEW	Sep 21, 2012	Substantially Equivalent	PRISM CLINICAL IMAGING, INC.
K121676	1.5T SIGNA HDXT 3.0T SIGNA HDXT SIGNA VIBRANT	Sep 20, 2012	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K121997	IMRIS ONCOLOGY PACKAGE	Aug 10, 2012	Substantially Equivalent	IMRIS, INC.
K122006	G-SCAN BRIO	Aug 06, 2012	Substantially Equivalent	ESAOTE, S.P.A.
K121160	MAGNETOM SPECTRA	Jul 16, 2012	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA INC.
K121650	S-SCAN	Jul 09, 2012	Substantially Equivalent	ESAOTE, S.P.A.
K121545	BELLYBOARD, SBRT ACCESSORIES	Jun 08, 2012	Substantially Equivalent	MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
K120638	VANTAGE TITAN	Jun 01, 2012	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION
K121239	MRI MULTI-CHANNEL OPTICAL COMMUNICATION (MOC) SYSTEM IMROC/IMROC IR WIRLESS OPTOACTIVE	May 24, 2012	Substantially Equivalent	OPTOACOUSTICS LTD
K120487	VANTAGE TITAN 3T	May 23, 2012	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION
K113281	MRI SYTEMS	May 17, 2012	Substantially Equivalent	SHENZHEN ANKE HIGH-TECH CO., LTD.
K113511	ECHOSTAR SPICA 1.5T MR SYSTEM	May 02, 2012	Substantially Equivalent	ALLTECH MEDICAL SYSTEMS AMERICA, INC.
K120748	SPEEDUP SOFTWARE OPTION	May 01, 2012	Substantially Equivalent	ESAOTE, S.P.A.
K113145	ECHELON OVAL MRI SYSTEM	May 01, 2012	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K120778	BRIVO MR355	Mar 27, 2012	Substantially Equivalent	GE HANGWEI MEDICAL SYSTEMS CO., LTD.
K113490	OPTIMA MR450W	Jan 13, 2012	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K113093	VANTAGE TITAN 3T	Jan 13, 2012	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION
K113337	VISIA DYNAMIC REVIEW	Dec 30, 2011	Substantially Equivalent	MEVIS MEDICAL SOLUTIONS AG
K112003	VANTAGE TITAN HSR	Dec 02, 2011	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION
K111242	MAGNETOM AERA AND MAGNETOM SKYRA	Nov 23, 2011	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K103327	DISCOVERY MR750W 3.0T	Sep 30, 2011	Substantially Equivalent	GE HEALTHCARE JAPAN CORPORATION
K102489	VANTAGE TITAN 3T	Aug 02, 2011	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN
K110942	PICA WHOLE-BODY MRI SYSTEM	Jul 26, 2011	Substantially Equivalent	TIME MEDICAL LIMITED
K111803	G-SCAN	Jul 15, 2011	Substantially Equivalent	ESAOTE, S.P.A.
K111226	ENDOSCOUT TRACKING SYSTEM	Jul 01, 2011	Substantially Equivalent	ROBIN MEDICAL, INC.
K111340	HEAD AND NECK IMMOBILIZATION SYSTEM, BODY IMMOBILIZATION SYSTEM	Jun 28, 2011	Substantially Equivalent	MEDTEC, INC.
K110802	A-CHANNELS LUMBAT SPINE COILS 17; 4-CHANNELS LUMBAR SPINE COILS 18	Apr 08, 2011	Substantially Equivalent	ESAOTE S.P.A.
K110151	ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T	Mar 22, 2011	Substantially Equivalent	PHILIPS HEALTHCARE
K103411	IDEAL IQ SOFTWARE OPTION	Mar 22, 2011	Substantially Equivalent	GE MEDICAL SYSTEMS
K110238	G-SCAN	Feb 17, 2011	Substantially Equivalent	ESAOTE S.P.A.
K103330	BRIVO MR355, OPTIMA MR360	Feb 11, 2011	Substantially Equivalent	GE HANGWEI MEDICAL SYSTEMS CO., LTD.
K103238	1.5T OPTIMA MR430S	Feb 11, 2011	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K103507	MEDICAL VISORS MV100	Feb 08, 2011	Substantially Equivalent	MEDICAL VISORS, INC
K102344	MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS	Nov 09, 2010	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K101813	IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO	Oct 05, 2010	Substantially Equivalent	IMRIS, INC.
K101347	MAGNETOM AERA; MAGNETOM SKYRA	Oct 01, 2010	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA INC.
K102155	MR RADIATION ONCOLOGY OPTIONS	Aug 31, 2010	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K101295	MROPEN	Jul 28, 2010	Substantially Equivalent	PARAMED SRL
K093738	MRI PATIENT POSITIONING DEVICES	May 14, 2010	Substantially Equivalent	MEDTEC, INC.
K100164	MR INSPIRE WITH EXTENDED KIT	Apr 05, 2010	Substantially Equivalent	PARAMED SRL
K093984	PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01	Mar 24, 2010	Substantially Equivalent	TIME MEDICAL LIMITED
K092308	POLESTAR, MODEL N-30	Mar 16, 2010	Substantially Equivalent	MEDTRONIC NAVIGATION ISRAEL, LTD.
K100352	DIAGNOSOFT HARP MODEL 2.06	Mar 11, 2010	Substantially Equivalent	DIAGNOSOFT, INC.
K093336	INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM	Mar 05, 2010	Substantially Equivalent	MEDICAL NUMERICS, INC.
K092925	3D ASL	Jan 06, 2010	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K092469	O-SCAN MR SYSTEM	Dec 23, 2009	Substantially Equivalent	ESAOTE S.P.A.
K092230	MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01	Nov 25, 2009	Substantially Equivalent	TIME MEDICAL LIMITED
K092899	OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4	Nov 10, 2009	Substantially Equivalent	NINGBO XINGAOYI MAGNETISM CO., LTD.
K092253	MODIFICATION TO FMRI HARDWARE SYSTEM	Oct 08, 2009	Substantially Equivalent	NORDICNEUROLAB
K092237	NSM-S15 SYSTEM	Sep 09, 2009	Substantially Equivalent	NEUSOFT MEDICAL SYSTEMS CO., LTD.
K091166	IMRX	Sep 02, 2009	Substantially Equivalent	IMRIS, INC.
K091580	PICA WHOLE BODY MRI SYSTEM	Jul 24, 2009	Substantially Equivalent	TIME MEDICAL LIMITED
K083421	MR-TOUCH OPTION	Jul 24, 2009	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K091444	PERFSCAPE	Jul 20, 2009	Substantially Equivalent	OLEA MEDICAL
K091536	OPTIMA MR450W	Jul 17, 2009	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K091669	OPEN MAGNETIC RESONANCE IMAGING SYSTEM, MODEL MPF3000-III	Jun 18, 2009	Substantially Equivalent	XIOAO MDT TECHNOLOGY CO LTD
K090038	SYNGO BREVIS	Apr 28, 2009	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA INC.
K090873	I OPEN 0.5T	Apr 10, 2009	Substantially Equivalent	BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD.
K090433	I_OPEN 0.4T	Mar 25, 2009	Substantially Equivalent	BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD.
K090080	CIRRUS OPEN	Mar 23, 2009	Substantially Equivalent	MRI-TECH SP. ZO.O.
K082964	PRISM ACQUIRE (VERSION 1.5), PRISM PROCESS (VERSION 1.5), PRISM VIEW (VERSION 2.5)	Mar 09, 2009	Substantially Equivalent	PRISM CLINICAL IMAGING, INC.
K083533	ECHELON C MRI SYSTEM	Feb 17, 2009	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K083137	NEURO III-SV	Dec 16, 2008	Substantially Equivalent	IMRIS, INC.
K082427	SYNGO MR B17	Nov 07, 2008	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K083147	DISCOVERY MR450	Nov 04, 2008	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K082331	MAGNETOM C!	Oct 01, 2008	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K073425	MODIFICATION TO AURORA MRI SYSTEM	Sep 16, 2008	Substantially Equivalent	AURORA IMAGING TECHNOLOGY, INC.
K082485	MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A	Sep 09, 2008	Substantially Equivalent	NEUSOFT MEDICAL SYSTEMS CO., LTD.
K082100	ALLTECH ECHOSTAR 1.5 T MR SYSTEM	Aug 06, 2008	Substantially Equivalent	ALLTECH MEDICAL SYSTEMS AMERICA, INC.
K081916	GE SIGNA MR ONCOLOGY PACKAGE	Jul 22, 2008	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K073362	MROPEN	May 23, 2008	Substantially Equivalent	PARAMED SRL
K080515	FMRI HARDWARE SYSTEM	May 16, 2008	Substantially Equivalent	NORDICNEUROLAB
K080762	IB NEURO, VERSION 1.0	May 15, 2008	Substantially Equivalent	IMAGING BIOMETRICS, LLC
K080968	S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA	Apr 29, 2008	Substantially Equivalent	ESAOTE S.P.A.
K081028	SIGNA 3.0T MR750 SYSTEM	Apr 25, 2008	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K080098	MRJ EXTENDED	Mar 10, 2008	Substantially Equivalent	PARAMED SRL
K073156	QPLAQUE MR	Mar 04, 2008	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K080048	MSK EXTREME MR SCANNER, MODEL AA5000	Feb 06, 2008	Substantially Equivalent	ONI MEDICAL SYSTEMS, INC.
K073457	MSTAR MPD4500	Feb 01, 2008	Substantially Equivalent	XINAOMDT TECHNOLOGY CO., LTD.
K080038	VANTAGE TITAN, MODEL MRT-1504/S3	Jan 22, 2008	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K073167	BRAINSTAT SOFTWARE OPTION FOR GE SIGNA MR SCANNER	Jan 04, 2008	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K072473	CHASE MR SYSTEM	Dec 10, 2007	Substantially Equivalent	CHASE MEDICAL, LP
K073081	JET SOFTWARE FOR EXCELART VANTAGE ATLAS-Z AND ATLAS-X	Nov 21, 2007	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K072850	MRI SYSTEM, MODEL MAGFINDER II / AI 3200	Nov 21, 2007	Substantially Equivalent	ADVANCED IMAGING LABORATORY
K073099	FMRI HARDWARE SYSTEM	Nov 20, 2007	Substantially Equivalent	NORDICNEUROLAB
K070968	CHOY COMPRESSION FRAME	Nov 15, 2007	Substantially Equivalent	CHOY MEDICAL TECHNOLOGIES, INC.
K072998	IDEAL SOFTWARE OPTION FOR GE MR SCANNERS	Nov 01, 2007	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K072237	MAGNETOM VERIO	Oct 10, 2007	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K072279	MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Sep 21, 2007	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K071925	MAGNETOM ESSENZA	Aug 14, 2007	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K071099	NEURO II-SE, MODELS: OR-DR-OR, OR-MB	May 22, 2007	Substantially Equivalent	IMRIS, INC.
K071154	SUPERSTAR 0.35T MRI SYSTEM	May 10, 2007	Substantially Equivalent	NEUSOFT MEDICAL SYSTEMS CO., LTD.
K063559	ACHIEVA, INTERA AND PANORAMA 1.0T, RELEASE 2.5	Jan 04, 2007	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K063361	EXCELART VANTAGE ATLAS, MODEL MRT-1503	Nov 21, 2006	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K063207	S-SCAN MRI SYSTEM	Nov 09, 2006	Substantially Equivalent	ESAOTE, S.P.A.
K062454	MAGNETOM SYSTEMS - I-CLASS AND T-CLASS RELEASES	Nov 03, 2006	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS, INC.
K062860	MODIFICATION TO SUPEROPEN 0.23T, MODEL NAM-P023A	Oct 27, 2006	Substantially Equivalent	NEUSOFT MEDICAL SYSTEMS CO., LTD.
K061916	NEURO II-SE, MODELS OR-MB-DR AND OR-DR	Aug 11, 2006	Substantially Equivalent	IMRIS, INC.
K061930	INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER ACCESSORY	Jul 28, 2006	Substantially Equivalent	FONAR CORP.
K061368	DIAGNOSOFT HARP	Jul 28, 2006	Substantially Equivalent	DIAGNOSOFT, INC.
K061429	DYNAMIC MRI SOFTWARE OPTION FOR C-SCAN, E-SCAN XQ AND E-SCAN OPERA	Jul 25, 2006	Substantially Equivalent	ESAOTE, S.P.A.
K061255	BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0	Jun 13, 2006	Substantially Equivalent	KYRON CLINICAL IMAGING, INC.
K061132	MODIFICATION TO SUPEROPEN 0.35T, MODEL NSM-P035	May 24, 2006	Substantially Equivalent	NEUSOFT MEDICAL SYSTEMS CO., LTD.
K060956	G-SCAN-MODEL 9800020000, E-SCAN MODEL 9800010000 AND E-SCAN XQ-MODELS-9800010011/9800010005,9800010009/9800010004	May 04, 2006	Substantially Equivalent	ESAOTE, S.P.A.
K053309	ALTAIRE INTERVENTIONAL MR PACKAGE	Jan 24, 2006	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K060003	EXCELART VANTAGE ZGV	Jan 18, 2006	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS CORPORATION
K052423	MAGNETOM SYSTEMS WITH SYNGO EXPERT - I OPTION	Jan 13, 2006	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS, INC.
K052023	CADIMAS VERSION 1.0	Dec 08, 2005	Substantially Equivalent	ALAN PENN & ASSOCIATES., INC.
K053009	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	Nov 17, 2005	Substantially Equivalent	GE MEDICAL SYSTEMS
K052978	GE 1.5T SIGNA HDE MR SYSTEM	Nov 09, 2005	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K052987	BREAST IMMOBILIZATION AND BIOPSY DEVICE, MODELS BI 160-O, BI 160-PA AND BI 160-CC	Nov 08, 2005	Substantially Equivalent	NORAS RONTGEN-UND MEDIZINTECHNIK GMBH
K052698	MODIFICATION TO: AURORA	Nov 08, 2005	Substantially Equivalent	AURORA IMAGING TECHNOLOGY, INC.
K052571	MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE (FDAD), VERSION 1.0	Oct 17, 2005	Substantially Equivalent	NEUROGNOSTICS, INC.
K052164	MAGNETOM SYSTEMS WITH SOFTWARE SYNGO MR 2006A	Oct 04, 2005	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K052579	PORTAL GRAVITY SYSTEM	Sep 27, 2005	Substantially Equivalent	PORTAL, INC.
K052172	HHF1 MAGNETIC RESONANCE IMAGING SYSTEM	Sep 27, 2005	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K052315	SIMTEC IM-MAXX 2 OPTION	Sep 22, 2005	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K052293	GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM	Sep 21, 2005	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K052305	MRI SOFT TISSUE MOTION CORRECTION SOFTWARE VA10A	Sep 08, 2005	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K052078	ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES	Sep 07, 2005	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K052013	ACHIEVA 1.5T & INERA 1.5T FAMILY	Aug 02, 2005	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
K050602	ALTAIRE	Apr 07, 2005	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K050237	STARSHIELD V3 RF TRNT	Mar 18, 2005	Substantially Equivalent	ODIN MEDICAL TECHNOLOGIES LTD.
K050200	MAGNETOM TRIO A TIM SYSTEM	Feb 28, 2005	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K050199	MAGNETOM SYMPHONY A TIM SYSTEM	Feb 18, 2005	Substantially Equivalent	SIEMENS MEDICAL SOLUTION
K050132	NEURO II-S	Feb 15, 2005	Substantially Equivalent	INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC.
K043147	ACHIEVA FAMILY	Feb 15, 2005	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K043290	MINDSTATE FUNCTIONAL DATA ACQUISITION DEVICE, VERSION 1.0	Jan 28, 2005	Substantially Equivalent	NEUROGNOSTICS, INC.
K043271	R2-MRI ANALYSIS SYSTEM	Jan 21, 2005	Substantially Equivalent	INNER VISION BIOMETRICS PTY LTD
K043262	GE SIGNA EXCITE MR SURGICAL OPTION	Jan 12, 2005	Substantially Equivalent	GE HEALTHCARE
K043030	MAGNETOM C! MR SYSTEM	Dec 09, 2004	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS
K043112	GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM	Nov 24, 2004	Substantially Equivalent	GENERAL ELECTRIC CO.
K042948	I OPEN 0.36 T-MAGNETIC RESONANCE IMAGING SYSTEM	Nov 03, 2004	Substantially Equivalent	WANDONG MEDICAL
K042236	G-SCAN	Oct 04, 2004	Substantially Equivalent	ESAOTE, S.P.A.
K041602	PANORAMA 1.0T	Jul 26, 2004	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K041695	LIBERTY 9000 8-CH BREAST COIL WITH DISPOSABLE BIOPSY PLATE	Jul 23, 2004	Substantially Equivalent	USA INSTRUMENTS, INC.
K041286	DYNACAD V1.0	Jul 21, 2004	Substantially Equivalent	MRI DEVICES CORP.
K041112	MAGNETOM ESPREE SYSTEM	Jul 21, 2004	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K041111	MAGNETOM C! MR SYSTEM	Jul 16, 2004	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K041020	CADSTREAM VERSION 3.1	Jul 07, 2004	Substantially Equivalent	CONFIRMA, INC.
K041577	PINNACLE3 RADIATION THERAPY PLANNING SYSTEM	Jun 25, 2004	Substantially Equivalent	ADAC LABORATORIES
K041476	GE SIGNA EXCITE 1.5T MR SYSTEM, GE SIGNA EXCITE 3.0T MR SYSTEM	Jun 17, 2004	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K040877	ARTOSCAN C	May 04, 2004	Substantially Equivalent	ESAOTE S.P.A.
K033485	ENDOSCOUT	Apr 20, 2004	Substantially Equivalent	ROBIN MEDICAL, INC.
K040444	GE SIGNA 3.0T WITH EXCITE MR SYSTEM	Apr 14, 2004	Substantially Equivalent	GENERAL ELECTRIC CO.
K033507	MRJ	Jan 20, 2004	Substantially Equivalent	PARAMED SRL
K033867	GE BRAINWAVE OPTION(S) FOR MRI SYSTEMS	Dec 19, 2003	Substantially Equivalent	GENERAL ELECTRIC CO.
K033504	GE 0.35T SIGNA OVATION WITH EXCITE MR SYSTEM	Nov 25, 2003	Substantially Equivalent	GENERAL ELECTRIC CO.
K033315	SUPEROPEN 0.23T, MODEL NAM-P023A	Oct 29, 2003	Substantially Equivalent	NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
K032428	MAGNETOM AVANTO MR SYSTEM	Oct 16, 2003	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K033168	GE 0.2T SIGNA PROFILE/I MR SYSTEM	Oct 10, 2003	Substantially Equivalent	GENERAL ELECTRIC CO.
K032795	GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM	Oct 08, 2003	Substantially Equivalent	GE MEDICAL SYSTEMS, LLC
K032232	AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE	Sep 29, 2003	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K032678	MODIFICATION TO: AURORA	Sep 24, 2003	Substantially Equivalent	AURORA IMAGING TECHNOLOGY, INC.
K032541	POLESTAR N-20	Sep 12, 2003	Substantially Equivalent	ODIN MEDICAL TECHNOLOGIES LTD.
K031815	INTERA-SENSATION FAMILY	Sep 10, 2003	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS
K032490	TOSHIBA EXCELART VANTAGE XGV/AGV MRI DIAGNOSTIC SYSTEM, MODELS MRT-1503/P3 AND MRT-1503/P2	Aug 21, 2003	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K032121	MODIFICATION TO E-SCAN XQ	Aug 13, 2003	Substantially Equivalent	ESAOTE S.P.A.
K032082	AURORA	Jul 30, 2003	Substantially Equivalent	AURORA IMAGING TECHNOLOGY, INC.
K031731	MR FIBER OPTIC ECG GATING SYSTEM	Jul 30, 2003	Substantially Equivalent	SA INSTRUMENTS, INC.
K031927	GE DELTA SOFTWARE OPTION FOR MRI	Jul 02, 2003	Substantially Equivalent	GE MEDICAL SYSTEMS
K030981	ECLIPSE	Jun 24, 2003	Substantially Equivalent	VARIAN MEDICAL SYSTEMS, INC.
K031350	3TP SOFTWARE OPTION	Jun 23, 2003	Substantially Equivalent	3TP LLC
K031396	ADVANTAGE WORKSTATION PASTING 1.1	May 13, 2003	Substantially Equivalent	GE MEDICAL SYSTEMS
K031230	GE PROPELLER IMAGING OPTION FOR MRI	May 02, 2003	Substantially Equivalent	GE MEDICAL SYSTEMS
K030918	SUPEROPEN 0.35T, MODEL NSM-P035	Apr 01, 2003	Substantially Equivalent	NEUSOFT DIGITAL MEDICAL SYSTEMS CO., LTD.
K030874	GE 3.0T SIGNA INFINITY TWINSPEED WITH EXCITE MR SYSTEM	Mar 28, 2003	Substantially Equivalent	GENERAL ELECTRIC CO.
K030520	INTERA FAMILY	Mar 06, 2003	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K024066	INFINION SOFTWARE FEATURES	Feb 04, 2003	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K024042	PANORAMA ENHANCEMENTS	Feb 04, 2003	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K023686	AURORA MR-GUIDED INTERVENTIONAL SYSTEM	Jan 29, 2003	Substantially Equivalent	AURORA IMAGING TECHNOLOGY, INC.
K023511	EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2	Nov 05, 2002	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K023130	ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM	Oct 11, 2002	Substantially Equivalent	MRI DEVICES CORP.
K022390	HITACHI ALTAIRE	Oct 11, 2002	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K023207	OPART (INCLUDING OPART ULTRA AND ULTRA GRADIENT UPGRADE KIT)	Oct 09, 2002	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K022157	RF TENT	Aug 28, 2002	Substantially Equivalent	ODIN MEDICAL TECHNOLOGIES LTD.
K022397	SIGNA 3.0T MAGNETIC RESONANCE SYSTEM	Aug 22, 2002	Substantially Equivalent	GE MEDICAL SYSTEMS
K020991	SYNGO MR 2002B	Jun 13, 2002	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K020268	ISAAC 1.5 T MR SYSTEM	Apr 25, 2002	Substantially Equivalent	CHI, INC.
K020289	MICS INTERVENTION AID, CATALOG # MICS-MIA AND MICS-MIAS	Apr 24, 2002	Substantially Equivalent	MACHNET BV
K020573	MODIFICATION TO MAGNETOM RHAPSODY SYSTEM	Mar 13, 2002	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K020164	E-SCAN XQ	Feb 12, 2002	Substantially Equivalent	BIOSOUND ESAOTE, INC.
K014011	CANVAS N-VAS-D 2.0	Feb 05, 2002	Substantially Equivalent	VASSOL, INC.
K013636	SIGNA INFINITY MR SYSTEM WITH EXCITE TECHNOLOGY	Jan 24, 2002	Substantially Equivalent	GE MEDICAL SYSTEMS
K013858	INFINION 0.6T MR IMAGING SYSTEM	Jan 22, 2002	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K013586	MAGNETOM TRIO SYSTEM	Dec 28, 2001	Substantially Equivalent	SIEMENS MEDICAL SYSTEMS, INC.
K010850	POLESTAR N-10	Dec 17, 2001	Substantially Equivalent	ODIN MEDICAL TECHNOLOGIES LTD.
K013344	INTERA I/T	Dec 11, 2001	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
K012875	SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM	Nov 20, 2001	Substantially Equivalent	GE MEDICAL SYSTEMS
K012495	OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS	Oct 31, 2001	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K013150	MR-GUIDE 2000	Oct 18, 2001	Substantially Equivalent	ULTRAGUIDE LTD.
K012202	NUMARIS 4VA15A	Sep 27, 2001	Substantially Equivalent	SIEMENS MEDICAL CORP.
K012970	GE SIGNA ASSET IMAGING OPTION	Sep 24, 2001	Substantially Equivalent	GE MEDICAL SYSTEMS
K012154	AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Sep 19, 2001	Substantially Equivalent	AURORA IMAGING TECHNOLOGY, INC.
K011416	MUSCLE IMAGING SYSTEM (MIS)	Aug 06, 2001	Substantially Equivalent	MILLENNIUM MAGNETIC IMAGING, INC.
K012200	1.5T INFINITY TWINSPEED MR SYSTEM	Aug 03, 2001	Substantially Equivalent	GE MEDICAL SYSTEMS
K011296	INFINION ENHANCEMENT PACKAGE	Jul 19, 2001	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K011485	PINNACLE MAGNETIC RESONANCE IMAGING SCANNER	Jun 06, 2001	Substantially Equivalent	FONAR CORP.
K011466	QED DIODE DETECTORS, MODELS 1112-1116	Jun 06, 2001	Substantially Equivalent	SUN NUCLEAR CORP.
K010773	BREAST BIOPSY DEVICE/MAGNETOM SYSTEMS	May 30, 2001	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K011418	ULTRAGUIDE MR-GUIDE 3000	May 24, 2001	Substantially Equivalent	ULTRAGUIDE LTD.
K010691	BLOOD OXYGENATION LEVEL DEPENDENT (BOLD) OPTION	May 08, 2001	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K002997	FIESTA IMAGING OPTION	Apr 11, 2001	Substantially Equivalent	GE MEDICAL SYSTEMS
K010570	BREAST IMMOBIIZATION AND BIOPSY DEVICE MR-BIOPSY 160	Apr 09, 2001	Substantially Equivalent	MRI DEVICES CORP.
K003899	IFIS-SA INTEGRATED FUCTIONAL IMAGING SYSTEM	Mar 15, 2001	Substantially Equivalent	MRI DEVICES CORP.
K003947	FUNCTIONAL BRAIN MAPPING OPTION FOR MRI	Mar 13, 2001	Substantially Equivalent	GE MEDICAL SYSTEMS
K003651	AURORA	Feb 21, 2001	Substantially Equivalent	AURORA IMAGING TECHNOLOGY, INC.
K003853	INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100	Feb 13, 2001	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K010057	MODIFICATION TO ARTOSCAN M	Feb 02, 2001	Substantially Equivalent	BIOSOUND ESAOTE, INC.
K003628	MAGNETOM RHAPSODY SYSTEM	Jan 23, 2001	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K003573	DIFFUSION TENSOR IMAGING OPTION	Jan 23, 2001	Substantially Equivalent	GE MEDICAL SYSTEMS, INC.
K003453	SYMPULSE COMPUTER SYSTEM FOR FONAR MRI SCANNERS	Jan 18, 2001	Substantially Equivalent	FONAR CORP.
K003516	GYROSCAN INTERA 3.0T	Dec 27, 2000	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K003623	INTERACTIVE REAL TIME SCANNING PACKAGE	Dec 21, 2000	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K003192	MAGNETIC CONCERTO	Dec 21, 2000	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K002964	NEURO II	Dec 19, 2000	Substantially Equivalent	INNOVATIVE MAGNETIC RESONANCE IMAGING SYSTEMS INC.
K002611	SIGNA MFO/I MAGNETIC RESONANCE SYSTEM	Oct 31, 2000	Substantially Equivalent	GE MEDICAL SYSTEMS
K002531	EXCELART WITH PIANISSIMO, MODEL MRT-1501/P3	Oct 26, 2000	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K002420	HITACHI ALTAIRE	Oct 17, 2000	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K002179	MAGNETOM ALLEGRA SYSTEM	Oct 11, 2000	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K002490	INDOMITABLE MAGNETIC RESONANCE IMAGING SCANNER	Oct 03, 2000	Substantially Equivalent	FONAR CORP.
K002242	POLESTAR N-10	Sep 20, 2000	Substantially Equivalent	ODIN TECHNOLOGIES LTD.
K001987	EXPLORER GRADIENT	Sep 06, 2000	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K001796	GYROSCAN INTERA (R7.5)	Sep 06, 2000	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K994283	MRI- MAGNETIC RESONANCE ANALYTICAL SOFTWARE SYSTEM	Aug 30, 2000	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K002415	POWERDRIVE 350 OPTION	Aug 18, 2000	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K001773	ORTHONE	Aug 18, 2000	Substantially Equivalent	ONI, INC.
K002225	OR TABLE/MAGNETOM OPEN VIVA SYSTEM	Aug 08, 2000	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K001894	MODIFICATION TO E-SCAN	Jul 06, 2000	Substantially Equivalent	BIOSOUND ESAOTE, INC.
K001334	HITACHI AIRIS II	Jul 06, 2000	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K000802	SPIRAL IMAGING OPTION	May 26, 2000	Substantially Equivalent	GE MEDICAL SYSTEMS
K000832	STEROTACTIC LOCALIZATION DEVICE (SLD)	Apr 27, 2000	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K000315	VENTRICULAR ANALYSIS TOOLKIT OPTION	Mar 27, 2000	Substantially Equivalent	GE MEDICAL SYSTEMS
K994351	M.R. VISION 2000 ULTRA AUDIO VISUAL SYSTEM / COMMANDER X6 SYSTEM	Mar 22, 2000	Substantially Equivalent	RESONANCE TECHNOLOGY, INC.
K994287	FONAR 360 DEGREE MAGNETIC RESONANCE IMAGING SCANNER	Mar 16, 2000	Substantially Equivalent	FONAR CORP.
K994282	MRI- FLOW ANALYTICAL SOFTWARE PACKAGE	Mar 02, 2000	Substantially Equivalent	MEDIS MEDICAL IMAGING SYSTEMS, B.V.
K993803	EXCELART WITH PIANISSIMO	Feb 06, 2000	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K994117	MR ENHANCER	Feb 04, 2000	Substantially Equivalent	I.Z.I. CORP.
K993682	MRI EQUIPMENT COVER	Jan 20, 2000	Substantially Equivalent	IMAGE-GUIDED NEUROLOGICS, INC.
K993574	OPART/PRODIGA, OPART/PROTENZA, OPART/PARAGON	Jan 18, 2000	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K994316	MAGNETOM OPEN VIVA WITH PERMANENT MAGNET	Jan 14, 2000	Substantially Equivalent	SIEMENS MEDICAL CORP.
K993731	SONATA GRADIENTS/MAGNETOM SYMPHONY SYSTEM	Dec 23, 1999	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K990329	PHILIPS EASYVISION WORKSTATION	Dec 07, 1999	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K992746	SIGNA HFO/I MAGNETIC RESONANCE SYSTEM	Nov 09, 1999	Substantially Equivalent	GE MEDICAL SYSTEMS, INC.
K990826	INTERACTIVE MR LOCALIZER/ MAGNETOM OPEN AND OPEN VIVA SYSTEM	Nov 01, 1999	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K992533	PHILIPS GYROSCAN INTERA (*)	Oct 18, 1999	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K990153	VIRGO MRI SYSTEM	Oct 08, 1999	Substantially Equivalent	MILLENNIUM TECHNOLOGY SERVICES
K983793	PREFERENCE TREATMENT SYSTEM	Oct 05, 1999	Substantially Equivalent	NORTHWEST MEDICAL PHYSICS EQUIPMENT, INC.
K992892	STEPPING KINEMATIC IMAGING PLATFORM (SKIP)	Sep 16, 1999	Substantially Equivalent	MAGNETIC MOMENTS, LLC.
K990335	PHILIPS EASYVISION WORKSTATION:	Sep 09, 1999	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K992135	SIGNA PROFILE/I MAGNETIC RESONANCE SYSTEM	Sep 08, 1999	Substantially Equivalent	GE MEDICAL SYSTEMS, INC.
K992225	QUANTITATIVE FLOW	Sep 07, 1999	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K991943	MRGP OPTICAL TRACKING UNIT	Aug 23, 1999	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K992412	IPASS BOLUS TRACKING	Aug 17, 1999	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K992120	DYNAWELL OR DYNAWELL	Aug 13, 1999	Substantially Equivalent	EKEROTH QUALITY AB
K991652	HIGH ENDS GRADIENTS/MAGNETOM SYMPHONY SYSTEM	Aug 03, 1999	Substantially Equivalent	SIEMENS CORP.
K991243	NORMA 10	Jun 18, 1999	Substantially Equivalent	ODIN TECHNOLOGIES LTD.
K990968	E-SCAN	May 27, 1999	Substantially Equivalent	BIOSOUND ESAOTE, INC.
K990620	EXCELART	May 14, 1999	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K990550	3.0T SIGNA VH/I MAGNETIC RESONANCE SYSTEM	May 11, 1999	Substantially Equivalent	GE MEDICAL SYSTEMS, INC.
K990260	OPART	Apr 15, 1999	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K983110	FLEXART,FLEXART/HYPER, VISART, VISART/HYPER	Feb 25, 1999	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K984221	FUNCTIONAL MRI PACKAGE FOR MAGETETOM VISION MR	Feb 12, 1999	Substantially Equivalent	SIEMENS CORP.
K984280	AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE	Feb 08, 1999	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K984224	PERFUSION PACKAGE FOR MAGNETOM VISION AND SYMPHONY SYSTEMS	Feb 02, 1999	Substantially Equivalent	SIEMENS CORP.
K984274	MAGNETIC RESONANCE DIAGNOSTIC DEVICE, VERSION 5.0 OPERATING SYSTEM SOFTWARE	Jan 25, 1999	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K983902	FIELD EFFECTS MRI SYSTEM	Jan 07, 1999	Substantially Equivalent	INTERMAGNETICS GENERAL CORP.
K982959	MEDRAD QUAD C-SPINE COIL, 1.5T MODEL, M64CSC, 1.0T MODEL M42CSC	Nov 03, 1998	Substantially Equivalent	MEDRAD, INC.
K982932	MEDRAD ANTERIOR NECK COIL, 1.5T & 1.0T MODEL NUMBERS M64ANC AND M42ANC	Nov 02, 1998	Substantially Equivalent	MEDRAD, INC.
K982834	RESTGRID PACKAGE/GYROSCAN NT	Oct 29, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K982761	JOINT MOTION DEVICE PACKAGE PN 1032,KNEEL CERVICAL PN 1026, LUMBAR 1027, WRIST 1028, ANKLE 1029, SHOULDER 1030, HIP 1031	Oct 22, 1998	Substantially Equivalent	CHAMCO, INC.
K983327	ACTIVE ECG ELECTRODES MAGNETOM VISION SYSTEMS	Oct 09, 1998	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K982157	TREX MRI MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Sep 02, 1998	Substantially Equivalent	FIELD EFFECTS
K980831	IMAGE POST-PROCESSING TECHNIQUES	Aug 27, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K981898	ORTHOVU-1000	Aug 03, 1998	Substantially Equivalent	MAGNEVU
K981475	OPART (MRT-600) VERSIONS 2 SOFTWARE UPGRADE	Jul 14, 1998	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K981410	HAMMERSMITH ENDOCAVITARY COILS	Jun 30, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K981190	HIGH IMPEDANCE CARDIAC GATING CABLE	Jun 30, 1998	Substantially Equivalent	GE MEDICAL SYSTEMS
K981398	ANATOMARK NONINVASIVE HEAD REFERENCE SYSTEM	Jun 01, 1998	Substantially Equivalent	INTERNEURON PHARMACEUTICALS, INC.
K980645	PHILIPS GYROSCAN NT RELEASE 6 SERIES	May 11, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K973658	DIFFUSION PACKAGE / GYROSCAN NT	May 06, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K980417	MEDRAD DISPOSABLE MRI KIT W/CHECK VALVE MODELSQK 65V, MEDRAD MRI INTEGRAL T WITH CHECK VALVE MODEL SIT 96V	May 04, 1998	Substantially Equivalent	MEDRAD, INC.
K980306	GYREX 2T PRESTIGE, GYREX PRIMA ITG, GYREX PRIVILEGE, GYREX V-EP	Apr 02, 1998	Substantially Equivalent	ELSCINT, INC.
K980114	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM	Mar 30, 1998	Substantially Equivalent	GE MEDICAL SYSTEMS
K974844	OUTLOOK SYSTEM ENHANCEMENT PACKAGE	Mar 10, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K974614	GYREX 2T PRESTIGE 100-6321-0107, GYREX PRIVILEDGE 100-6326-0102, GYREX PRIMA 1TG 100-6250-0102	Mar 04, 1998	Substantially Equivalent	ELSCINT, INC.
K974498	STRATIS II	Feb 26, 1998	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K974212	AIRIS II	Feb 09, 1998	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K974530	DUFFUSION-WEIGHTED MR IMAGING PACKAGE	Feb 06, 1998	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K972990	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM	Feb 05, 1998	Substantially Equivalent	GE MEDICAL SYSTEMS
K973799	CARDIAC TAGGING TECHNIQUES/MAGNETOM VISION AND MAGNETOM IMPACT	Jan 02, 1998	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K972826	ESTEEM 1.5T MRI SYSTEM	Oct 15, 1997	Substantially Equivalent	ELSCINT MR, INC.
K972704	KINEMATIC POSITIONERS	Sep 29, 1997	Substantially Equivalent	GE MEDICAL SYSTEMS, INC.
K970990	GYREX PRIMA 1TG 1.0T MRI SYSTEM	Aug 25, 1997	Substantially Equivalent	ELSCINT MR, INC.
K971884	ASSET APOLLO	Aug 20, 1997	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K971684	MAGNETOM PROJECT 047 SYSTEM (NUMARIS 3.5 SOFTWARE)	Aug 05, 1997	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K971668	SIGNA PROFILE WRIST COIL AND MOBILE SITING OPTIONS	Jul 24, 1997	Substantially Equivalent	GE MEDICAL SYSTEMS
K970573	FLEXART V3.5 SOFTWARE	Jul 21, 1997	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K965068	MAGNETIC RESONANC DVCE VISART V 3.5 SOFTWARE	Jul 15, 1997	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K971380	MEDRAD FLEX INTERFACE DEVICE	Jul 03, 1997	Substantially Equivalent	MEDRAD, INC.
K971279	VERSION 4 OPERATING SYSTEM SOFTWARE	Jul 03, 1997	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K971055	DIFFUSION WEIGHTED MR IMAGING /MAGNETOM VISION	Jun 20, 1997	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K965044	GYREX 2T PRESTIGE MODEL NO. 100-6321-0107 AND GYREX PRIVILEGE MODEL NO. 100-6326-0102	Jun 16, 1997	Substantially Equivalent	ELSCINT, INC.
K970852	MAGNETOM PROJECT 024 SYSTEM (NUMARIS 3.5 SOFTWARE)	Jun 05, 1997	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K963990	GYROSCAN T5-NT, GYROSCAN T10-NT AND GYROSCAN ACS-NT RELEASE 5 SERIES	May 29, 1997	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K963262	ARTOSCAN M	Mar 28, 1997	Substantially Equivalent	BIOSOUND, INC.
K970037	TARGOGRID	Mar 12, 1997	Substantially Equivalent	DAUM GMBH
K964778	HI-STAR MRI IMAGING SYSTEM	Feb 24, 1997	Substantially Equivalent	HEALTH IMAGES, INC.
K964752	KINEMATIC POSITIONING DEVICES; C-SPINE, KNEE,SHOULDER	Feb 24, 1997	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K964753	MATRIX 3000 FLEXIBLE SPINE COIL	Feb 11, 1997	Substantially Equivalent	US ASIA INSTRUMENTS, INC.
K964626	EDGE/VISTA SYSTEM ENHANCEMENT PACKAGE	Feb 10, 1997	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K964608	MRT-35A V9.0	Feb 04, 1997	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K964531	PROFILE 70000 QUADRATURE VOLUME NECK COIL	Jan 24, 1997	Substantially Equivalent	US ASIA INSTRUMENTS, INC.
K964306	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	Jan 17, 1997	Substantially Equivalent	GENERAL ELECTRIC CO.
K964370	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM	Jan 10, 1997	Substantially Equivalent	GE MEDICAL SYSTEMS
K962249	PIXELL MRI SYSTEM	Jan 10, 1997	Substantially Equivalent	GENERAL MEDICAL EQUIPMENT CORP.
K962138	FLEXART V3.1 SOFTWARE	Dec 23, 1996	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K963953	IMIG-MRI	Dec 18, 1996	Substantially Equivalent	IMIG-MRI SYSTEMS, LLC.
K963429	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM	Nov 27, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K962061	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM	Nov 27, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K963186	ORTHO 8000	Nov 12, 1996	Substantially Equivalent	INNER VISION MRI LTD.
K963179	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM	Nov 07, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K962892	HELAX TMS BRACHYTHERAPY, VERSION 3.0	Oct 29, 1996	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K962933	OPART MRT-600	Oct 25, 1996	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K963345	ADVANTAGE WINDOWS TISSUE VOLUME OPTION	Oct 18, 1996	Substantially Equivalent	GE MEDICAL SYSTEMS
K961624	FLEXART TMJ COIL	Oct 18, 1996	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K962927	IN-ROOM MRC/ MAGNETOM VISION AND IMPACT SYSTEMS	Sep 25, 1996	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K962677	ESTEEM 1.5T MRI SYSTEM	Sep 20, 1996	Substantially Equivalent	ELSCINT MR, INC.
K961969	HITACHI STRATIS, MRH-1500 MAGNETIC RESONANCE DIAGNOSTIC DEVICES VERSION 6 OPERATING SYSTEM SOFTWARE	Sep 05, 1996	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K962618	GYREX V-EP	Sep 04, 1996	Substantially Equivalent	ELSCINT, INC.
K962117	QUADRATURE AND PHASED ARRAY FLEXIBLE BODY COILS	Aug 27, 1996	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K962048	1W/KG SAR(PART OF VERSION 6-05 OPERATING SYSTEM SOFTWARE)	Aug 14, 1996	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K961842	SOFTWARE VERSION 8.5CD OF THE MRT-35A MAGNETIC RESONANCE IMAGING SYSTEM	Aug 02, 1996	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K961876	AIRIS	Jul 25, 1996	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K960497	FLEXIBLE PHASED ARRAY SPINE COIL	Jul 05, 1996	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K961366	MODEL #QSC-200-4C AND QSC-165-4C ARRAY SHOULDER COILS	Jul 03, 1996	Substantially Equivalent	MRI DEVICES CORP.
K961238	MRT-50A/150A SOFTWARE UPGRADE V12.0/12.1	Jun 28, 1996	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K961174	ECG MONITOR MODEL DS-3130/3140	Jun 21, 1996	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K961121	KINEMATIC KNEE DEVICE/MAGNETOM OPEN SYSTEM	Jun 19, 1996	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K961092	VISART	Jun 14, 1996	Substantially Equivalent	TOSHIBA AMERICA MEDICAL SYSTEMS, INC.
K955389	MR GUIDED PROCEDURES PACKAGE/MAGNETOM OPEN SYSTEM	Jun 10, 1996	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K960973	MOVABLE ADD-ON COUCH FOR OUTLOOK	May 29, 1996	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K960901	MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURFACE COIL	May 29, 1996	Substantially Equivalent	MEDRAD, INC.
K960294	PHASE CONJUGATE SYMMETRY OPTION FOR OUTLOOK	Apr 19, 1996	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K954354	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	Apr 12, 1996	Substantially Equivalent	GENERAL ELECTRIC CO.
K954353	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	Apr 12, 1996	Substantially Equivalent	GENERAL ELECTRIC CO.
K955811	AUXILIARY PATIENT TABLE/MAGNETOM OPEN SYSTEM	Mar 29, 1996	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K960181	VERSION 3.7 OPERATING SYSTEM SOFTWARE	Mar 05, 1996	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K950837	AURORA IMAGING SYSTEM	Feb 26, 1996	Substantially Equivalent	ADVANCED MAMMOGRAPHY SYSTEMS, INC.
K954646	EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS	Jan 18, 1996	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K945945	GYROSCAN ACS-NT, GYROSCAN T5-NT AND GYROSCAN T10-NT	Dec 22, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K954039	GYREX PRIVILEGE	Nov 24, 1995	Substantially Equivalent	ELSCINT, INC.
K942604	SIGNA ADVANTAGE SP MAGNETIC RESONANCE SYSTEM	Nov 24, 1995	Substantially Equivalent	GE MEDICAL SYSTEMS
K954355	ADVANTAGE WINDOWS 3D WITH NAVIGATOR OPTION	Nov 14, 1995	Substantially Equivalent	GENERAL ELECTRIC CO.
K951650	CLINICAL PROTON SPECTROSCOPY OPTION	Nov 14, 1995	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K951681	QUAD 1200 MAGNETIC RESONANCE IMAGING SCANNER	Nov 09, 1995	Substantially Equivalent	FONAR CORP.
K953248	IRIS BILATERAL TMJ	Oct 23, 1995	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K953262	QD BILATERAL BREAST COIL	Oct 17, 1995	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K945517	MAGNETOM VISION (PROJECT 016)	Oct 07, 1995	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K943440	PROFILE 7000 C-SPINE COIL	Oct 06, 1995	Substantially Equivalent	US ASIA INSTRUMENTS, INC.
K945791	GYRES 2T PRESTIGE	Sep 19, 1995	Substantially Equivalent	ELSCINT, INC.
K945827	OUTLOOK	Sep 18, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K953918	MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Sep 12, 1995	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K944724	HEALTH IMAGE INC. HI STAR	Aug 30, 1995	Substantially Equivalent	HEALTH IMAGES, INC.
K945779	MAGNETOM VISION (PROJECT 016)	Aug 23, 1995	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K945730	SIGNA PROFILE	Aug 09, 1995	Substantially Equivalent	GE MEDICAL SYSTEMS
K943189	MEDRAD QWIK-FIX MRI DISPOSABLE KIT	Aug 09, 1995	Substantially Equivalent	MEDRAD, INC.
K952530	HEAD/NECK VASCULAR PHASED ARRAY COIL PACKAGE	Jul 24, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K944228	HEALTH IMAGES, INC. HI-STANDARD	Jul 20, 1995	Substantially Equivalent	HEALTH IMAGES, INC.
K952235	MRIINNERVU DISPOSABLE ENDORECTAL CERVIC COIL, CATALOG NO. BCR-15	Jun 26, 1995	Substantially Equivalent	MEDRAD, INC.
K952232	MRINNERVU DISPOSABLE ENDORECTAL COLON COIL, CATALONG NO. PCC-15	Jun 26, 1995	Substantially Equivalent	MEDRAD, INC.
K951649	MODEL #801GE1500 PEDIATRIC ARRAY COIL	Jun 22, 1995	Substantially Equivalent	MEDIC, INC.
K944070	ADVANCED NMR SYST INSTASCAN/MODIF: T1 & TE STEPPING	Jun 19, 1995	Substantially Equivalent	ADVANCED NMR SYSTEMS, INC.
K941666	SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM-HISPEED PERFORMANCE OPTIONS	Jun 19, 1995	Substantially Equivalent	GENERAL ELECTRIC CO.
K944979	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	Jun 13, 1995	Substantially Equivalent	GE MEDICAL SYSTEMS
K946085	THIN-FILM CARDIAC GATING CABLE	Jun 05, 1995	Substantially Equivalent	GENERAL ELECTRIC CO.
K945155	AIRIS	May 24, 1995	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K943798	MRH-1500	May 12, 1995	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K950973	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM	May 11, 1995	Substantially Equivalent	GE MEDICAL SYSTEMS
K945875	MRT-50 QD BODY COIL	Apr 20, 1995	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K945828	ECHO PLANAR IMAGING I	Apr 12, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K940772	ECHO(TM) (QUAD(TM) 7000 MAGNETIC RESONANCE IMAGING SCANNER)	Apr 10, 1995	Substantially Equivalent	FONAR CORP.
K945798	MRT-35A UPGRADE 8.0CD	Apr 06, 1995	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K945665	FLEXART(TM) QD C-SPINE COIL	Apr 06, 1995	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K945778	PHASED ARRAY SHOULDER COIL, QUADRATURE SHOULDER COIL	Mar 23, 1995	Substantially Equivalent	MEDICAL ADVANCES, INC.
K945386	STRATIS	Mar 21, 1995	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K945397	ANGIO II	Feb 09, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K946244	ACCESS(TM) COMPASS BED	Feb 08, 1995	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K942669	SMT-50CX/H	Feb 02, 1995	Substantially Equivalent	SHIMADZU MEDICAL SYSTEMS
K941864	MRT-150A, MRT-150A SOFTWARE VERSION 11.9	Jan 26, 1995	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K941622	ECHO PLANAR IMAGING OPTION FOR THE MAGNETOM VISION	Jan 26, 1995	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K944773	MODEL 405GE-64: PHASED ARRAY TMJ COIL	Jan 25, 1995	Substantially Equivalent	MEDICAL ADVANCES, INC.
K944662	FLEXART QD BODY COIL	Jan 25, 1995	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K944469	GENERAL PURPOSE FLEX COIL	Jan 25, 1995	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K944331	MODEL 528GE SERIES	Jan 25, 1995	Substantially Equivalent	MEDICAL ADVANCES, INC.
K943800	2D,3D, TOF MR ANGIOGRAPHY	Dec 30, 1994	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K941582	SUPERSENSOR MRI COIL	Dec 23, 1994	Substantially Equivalent	SUPERCONDUCTOR TECHNOLOGIES, INC.
K944112	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	Dec 22, 1994	Substantially Equivalent	GE MEDICAL SYSTEMS
K943415	MERIT (O.1T MR SYSTEM)	Dec 15, 1994	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K943799	VERSION 5 OPERATING SYSTEM SOFTWARE	Dec 09, 1994	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K942874	MODEL #300TO3500 SHOULDER COIL	Dec 08, 1994	Substantially Equivalent	MEDIC, INC.
K942875	MODEL #900TO3500 HEAD/NECK COIL	Dec 02, 1994	Substantially Equivalent	MEDIC, INC.
K942873	MODEL #700TO3500 NECK/ABDOMINAL COIL	Dec 02, 1994	Substantially Equivalent	MEDIC, INC.
K943320	HEAD AND NECK COIL FOR THE GYREX 2T-DLX	Nov 29, 1994	Substantially Equivalent	ELSCINT, INC.
K940534	GYROSCAN T10-NT (RELEASE 4 SERIES SOFTWARE)	Nov 22, 1994	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K940541	MAGNETIC RESONANCE DIAG DEVICE MAGNETOM VISION (MODIF)	Nov 07, 1994	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K943021	MRT-150A	Oct 14, 1994	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K942953	ORACLE MRI WHOLE BODY MR IMAGING SYSTEM	Sep 30, 1994	Substantially Equivalent	OTSUKA ELECTRONICS USA, INC.
K943321	QUAD PELVIS COIL	Sep 23, 1994	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K942776	MAGNETIC RESONANCE ANGIOGRAPHY CAPABILITY/OE 1.5 S1	Sep 21, 1994	Substantially Equivalent	OTSUKA ELECTRONICS USA, INC.
K942355	MODEL #310T03500 WRIST COIL	Sep 16, 1994	Substantially Equivalent	MEDIC, INC.
K934987	CP-SPINE COILS FOR GYREX 2T-DLX & V-DLX	Sep 16, 1994	Substantially Equivalent	ELSCINT, INC.
K942560	MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Sep 09, 1994	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K942609	MRT-150A SHOULDER COIL	Sep 02, 1994	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K940894	MAGNA SL	Sep 02, 1994	Substantially Equivalent	MAGNA-LAB, INC.
K941996	EDGE	Aug 25, 1994	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K935549	GYREX 2T-SGR	Aug 24, 1994	Substantially Equivalent	ELSCINT, INC.
K940796	ACCESS	Aug 23, 1994	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K934318	DIAGNOSTIC INSTRUMLENTS INC. MODEL T803 BREAST COIL	Aug 22, 1994	Substantially Equivalent	DIAGNOSTIC INSTRUMENT CORP.
K941812	SLICES	Aug 12, 1994	Substantially Equivalent	MICROSIGNAL CORP.
K935691	MODEL GP-252 GENERAL PURPOSE COIL	Aug 01, 1994	Substantially Equivalent	DIAGNOSTIC INSTRUMENT CORP.
K941408	MERIT	Jul 28, 1994	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K935224	VOLUME NECK COIL FOR THE GYREX V-DIX	Jun 27, 1994	Substantially Equivalent	ELSCINT, INC.
K930193	PHILIPS ENDO-CAVITARY MRI COIL	Jun 24, 1994	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K940364	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	Jun 21, 1994	Substantially Equivalent	MEDICAL ADVANCES, INC.
K934514	CATCH AND HOLD OPTION FOR INSTASCAN	Jun 21, 1994	Substantially Equivalent	ADVANCED NMR SYSTEMS, INC.
K941025	PHASED ARRAY BREAST COIL	Jun 08, 1994	Substantially Equivalent	MEDICAL ADVANCES, INC.
K940874	MODEL 900GE1500 HEAD/NECK COIL	Jun 03, 1994	Substantially Equivalent	MEDIC, INC.
K940602	EXTRA LARGE QUAD FLEX SPINE COIL	May 23, 1994	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K935015	QUADRATURE SMALL EXTREMITY COIL	May 10, 1994	Substantially Equivalent	MAGNETIC RESEARCH, INC.
K940514	41OTO-15: SHOULDER COIL SET 411TO-15 412TO-15	May 05, 1994	Substantially Equivalent	MEDICAL ADVANCES, INC.
K934538	MRI RESONANCE DIAGNOSTIC DEVICE ACCESORY	Apr 25, 1994	Substantially Equivalent	NOISE CANCELLATION TECHNOLOGIES
K935671	2D, 3D TOF MR ANGIOGRAPHY	Mar 30, 1994	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K935670	VERSION 3 OPERATING SYSTEM SOFTWARE	Mar 30, 1994	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K935752	CP FLEXIBLE COILS/ LP CIRCULAR FLEX COILS	Mar 29, 1994	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K935627	CP BODY ARRAY/ CP SPINE ARRAY COIL	Mar 29, 1994	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K935450	PHASED ARRAY PELVIC COIL	Mar 25, 1994	Substantially Equivalent	MEDICAL ADVANCES, INC.
K935369	FAST SPIN ECHO (FSE)	Mar 21, 1994	Substantially Equivalent	RESONEX, INC.
K933296	MODEL #310GE1500 WRIST COIL	Mar 17, 1994	Substantially Equivalent	MEDIC, INC.
K933295	MODEL 700GE1500 CARDIAC VASCULAR COIL FOR G.E. 1.5T SIGNA	Mar 17, 1994	Substantially Equivalent	MEDIC, INC.
K935664	FAST SPIN ECHO	Mar 16, 1994	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K935661	MAGNETOM OPEN	Mar 16, 1994	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K935570	NOISE FILTER FOR PARADIGM MAGNETIC RESONANCE IMAGING SYSTEM	Mar 16, 1994	Substantially Equivalent	RESONEX, INC.
K931460	VECTRA MOBILE MAGNETIC RESONANCE IMAGING SYSTEM	Mar 04, 1994	Substantially Equivalent	GENERAL ELECTRIC CO.
K932403	AUTOTUNE DEVICE (ATD II)/PHILIPS S-15/ACS MRI SCAN	Feb 24, 1994	Substantially Equivalent	MEDRAD, INC.
K933018	MRT-50GP	Feb 18, 1994	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K932244	SMT-100X/H AND SMT-100X/X MAGNETIC RESONANCE IMAGING SYSTEM	Feb 18, 1994	Substantially Equivalent	SHIMADZU MEDICAL SYSTEMS
K935084	INCREASED SAR PACKAGE FOR MRT-150A	Feb 09, 1994	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K932552	SPORTS MEDICINE QUADRATURE SHOULDER COIL	Feb 09, 1994	Substantially Equivalent	MAGNETIC RESEARCH, INC.
K934485	HITACHI MPR-5000 & MPR-7000 MAGNETIC RESONANCE DIAGNOSTIC DEVICE MODIFICATION	Jan 25, 1994	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K930708	PHILIPS GYROSCAN T5 II RELEASE 3	Jan 25, 1994	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K931298	SIGNA ADVANTAGE 1.OT MAGNETIC RESONANCE SYSTEM	Jan 18, 1994	Substantially Equivalent	GENERAL ELECTRIC CO.
K932271	MAGNETIC RESON DIAG DEVICE MAGNETOM PROJECT 016	Jan 07, 1994	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K934719	EXTRA LARGE QUAD FLEX SPINE COIL	Jan 05, 1994	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K934212	FAST SPIN ECHO	Dec 27, 1993	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K934499	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	Dec 23, 1993	Substantially Equivalent	GE MEDICAL SYSTEMS
K933356	MERIT	Dec 14, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K932091	PHASED ARRAY/BILATERAL QUADRATURE CONTOUR COIL	Dec 14, 1993	Substantially Equivalent	MAGNETIC RESEARCH, INC.
K931656	MERIT	Dec 14, 1993	Substantially Equivalent	PICKER INTERNATIONAL
K931454	IMAGEACCESS SYSTEM	Dec 14, 1993	Substantially Equivalent	IMAGE PREMASTERING SERVICES, INC.
K932645	PHILIPS GYROSCAN TN 15	Dec 13, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K932644	PHILIPS GYROSCAN TN5 & TN5 LITE	Dec 13, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K925858	OE 1.5 SI	Dec 02, 1993	Substantially Equivalent	OTSUKA ELECTRONICS
K934396	QUADRATURE LOWER EXTREMITY COIL	Nov 24, 1993	Substantially Equivalent	MEDICAL ADVANCES, INC.
K933835	0.5T ASSET SYSTEM	Nov 22, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K933659	MODEL #100GE1500 LOWER EXTREM QUAD DETECT ARRAY COIL	Nov 22, 1993	Substantially Equivalent	MEDIC, INC.
K931544	1.5T EDGE AND 1.0T VISTA SYSTEMS	Nov 22, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K933658	MODEL 300GE1500 SHOULDER COIL	Nov 19, 1993	Substantially Equivalent	MEDIC, INC.
K933645	ECG GATING HARDWARE FOR MRP-5000 AND MRP-7000	Nov 12, 1993	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K930709	PHILIPS GYROSCAN ACS-II RELEASE 3	Nov 08, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K933297	MODEL #510GE1500 LIVER ARRAY COIL	Nov 02, 1993	Substantially Equivalent	MEDIC, INC.
K931392	ECG GATING UNIT	Nov 02, 1993	Substantially Equivalent	RESONEX, INC.
K930960	ACCESS MAGNETIC RESONANCE DEVICE ACCESSORY	Nov 01, 1993	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K926275	PHILIPS MRI BREAST COIL	Oct 28, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K932344	MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES	Oct 25, 1993	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K926001	MRT-50A, MRT-150A	Oct 08, 1993	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K932693	EDGE SYSTEM	Oct 07, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K931022	ARTOSCAN	Oct 07, 1993	Substantially Equivalent	BIOSOUND, INC.
K930779	MRINNERVU DISPOSABLE ENDORECTAL CERVIX COIL#BCR-15	Oct 07, 1993	Substantially Equivalent	MEDRAD, INC.
K925985	GYREX V-DIX & 2T-DIX SOFTWARE VERSION 3.0	Oct 07, 1993	Substantially Equivalent	ELSCINT, INC.
K925597	SNR-3000 UPGRADE RECEIVER COILS	Oct 07, 1993	Substantially Equivalent	MAGNETIC RESONANCE PLUS, INC.
K925286	MRT-150A MRI SYSTEM W/SUPER PERFORMANCE PACKAGE	Oct 07, 1993	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K930544	MRINNERVU DISPOSABLE ENDORECTAL COLON COIL,#PCC-15	Sep 29, 1993	Substantially Equivalent	MEDRAD, INC.
K930674	MODEL 640GE-64: QUADRATURE PELVIC COIL	Sep 16, 1993	Substantially Equivalent	MEDICAL ADVANCES, INC.
K932375	MAG RES DIAG DEV ACCESS CIR POL(CP) BODY/SPINE COI	Sep 07, 1993	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K932374	MAG RESON DIAG DEVI ACCESS CIR POLAR(CP) HEAD COIL	Sep 07, 1993	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K930811	MODIFIED BODY HELMHOLTZ COIL	Sep 07, 1993	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K932338	MAGNETOM P8	Aug 30, 1993	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K932292	AUTOTUNE DEVICE (ATD II) FOR PICKER MRI SYSTEMS	Aug 26, 1993	Substantially Equivalent	MEDRAD, INC.
K930122	MODEL 600GE-64: BILATERAL BREAST COIL	Jul 26, 1993	Substantially Equivalent	MEDICAL ADVANCES, INC.
K930045	MODEL #QSC-200-21 20 CM. QUADRATURE SHOULDER COIL	Jul 26, 1993	Substantially Equivalent	MRI DEVICES CORP.
K926571	MRINNERVU(R) ENDORECTAL PROSTATE COIL BPX-15	Jul 20, 1993	Substantially Equivalent	MEDRAD, INC.
K931008	MODEL #QWH-63, QUADRATURE WRIST AND HAND COIL	Jun 18, 1993	Substantially Equivalent	MRI DEVICES CORP.
K930991	BILATERAL TEMPORAL MANDIBULAR JOINT COIL	Jun 18, 1993	Substantially Equivalent	MAGNETIC RESEARCH, INC.
K922846	MRH-1500	Jun 08, 1993	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K924605	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	May 21, 1993	Substantially Equivalent	GENERAL ELECTRIC CO.
K926416	SAT PAD(TM)	May 19, 1993	Substantially Equivalent	ALLIANCE PHARMACEUTICAL CORP.
K925987	INSTRUMENTARIUM MEGA4 HT	May 19, 1993	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K925029	MRINNERVU ENDORECTAL PROSTATE COIL	May 19, 1993	Substantially Equivalent	MEDRAD, INC.
K924921	INSTRUMENTARIUM MEGA4 HT	May 17, 1993	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K921891	SILENT SCAN	May 13, 1993	Substantially Equivalent	AVOTEC, INC.
K924472	INSTRUMENTARIUM MEGA4 HT	May 03, 1993	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K923581	INSTRUMENTARIUM MEGA4 HT	May 03, 1993	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K926171	MRT-150A, QD SPINE COIL	Apr 27, 1993	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K924808	MRT-50A SUPER	Apr 27, 1993	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K923944	PHILIPS GYROVIEW HR - RELEASE 2	Apr 27, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K926397	FAST SPIN ECHO MEASURING FUNCTION	Mar 18, 1993	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K923984	SMT-50X/H MAGNETIC RESONANCE IMAGING SYSTEM	Mar 16, 1993	Substantially Equivalent	SHIMADZU MEDICAL SYSTEMS
K925009	2D TOF ANGIOGRAHY MEASURING FUNCTION	Feb 12, 1993	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K925845	VISTA HP/HPQ SYSTEM	Feb 02, 1993	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K925107	SMT-50XM MAGNETIC RESONANCE IMAGING SYSTEM	Jan 15, 1993	Substantially Equivalent	SHIMADZU MEDICAL SYSTEMS
K924489	SOFTWARE VERSION A2.5 FOR MAGNETOM 42SP/63SP SYST	Jan 15, 1993	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K923870	3DTOF MRA	Jan 12, 1993	Substantially Equivalent	RESONEX, INC.
K924756	MAG RES DIAG DEVI ACCESS CIR POLAR(CP) SPINE COIL	Dec 30, 1992	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K924653	MODEL #QBC-17, 17CM. QUADRATURE BREAST COIL	Dec 24, 1992	Substantially Equivalent	MRI DEVICES CORP.
K924479	MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES	Dec 24, 1992	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K923423	QUADATURE HEAD/NECK/VASCULAR COIL	Dec 24, 1992	Substantially Equivalent	MEDICAL ADVANCES, INC.
K923140	MRP-5000 AND 7000 BILATERAL/UNILATERAL TMJ COIL	Dec 24, 1992	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K921653	VECTRA MAGNETIC RESONANCE SYSTEM	Dec 24, 1992	Substantially Equivalent	GENERAL ELECTRIC CO.
K924426	MAGNETIC RESONANCE DIAG DEVICE ACCESS APPLIC PKG	Dec 18, 1992	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K924349	GENERAL PURPOSE FLEX COIL, CATALOG NUMBER M1685GP	Nov 27, 1992	Substantially Equivalent	GENERAL ELECTRIC CO.
K923025	SIGNA BREAST COIL AND ARRAY ACCESSORY	Nov 27, 1992	Substantially Equivalent	GE MEDICAL SYSTEMS
K922470	IES, IMAGE ENHANCEMENT SYSTEM	Nov 27, 1992	Substantially Equivalent	OPEN MRI, INC.
K924154	KINEMATIC MRI MOVIEMAKER	Nov 23, 1992	Substantially Equivalent	RESONEX, INC.
K921940	MRT-35(TM)	Nov 10, 1992	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K921941	SIGNA ADVANTAGE 0.5T MAG RESON SYS-FAST ACQUIS OPT	Nov 09, 1992	Substantially Equivalent	GENERAL ELECTRIC CO.
K923948	SAT PAD	Nov 06, 1992	Substantially Equivalent	ALLIANCE PHARMACEUTICAL CORP.
K920791	GYROSCAN S15/ACS-II	Nov 06, 1992	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K920578	PHILIPS GYROSCAN T5 SERIES II	Nov 06, 1992	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K923881	QUADRATURE CERVICAL CONTOUR COIL	Nov 05, 1992	Substantially Equivalent	MAGNETIC RESEARCH, INC.
K923823	3D IMAGING	Oct 30, 1992	Substantially Equivalent	RESONEX, INC.
K923897	A BREAST COIL FOR THE GYREX 2T-DIX	Oct 21, 1992	Substantially Equivalent	ELSCINT, INC.
K923615	VISTA HPQ SYSTEM	Oct 09, 1992	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K923352	INSTRUMENTARIUM MEGA4 HT	Oct 06, 1992	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K923264	GENERAL PURPOSE FLEX COIL	Sep 30, 1992	Substantially Equivalent	GENERAL ELECTRIC CO.
K923022	INSTRUMENTARIUM MEGA4 HT	Sep 22, 1992	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K922798	QD WHOLE BODY COIL, MRT-150A	Sep 14, 1992	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K922677	MAGNETIZATION TRANSFER CONTRAST	Sep 04, 1992	Substantially Equivalent	RESONEX, INC.
K923010	MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Aug 25, 1992	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K920227	QUADRATURE SHOULDER CONTOUR COIL	Aug 24, 1992	Substantially Equivalent	MAGNETIC RESEARCH, INC.
K920714	VISTA HPQ SYSTEM	Aug 20, 1992	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K921413	MRT-50	Aug 14, 1992	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K920204	INSTASCAN	Aug 05, 1992	Substantially Equivalent	ADVANCED NMR SYSTEMS, INC.
K920441	3D TOF ANGIOGRAPHY MEASURING FUNCTION	Jul 30, 1992	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K922006	QQUADRATURE LUMBAR CONTOUR COIL	Jul 29, 1992	Substantially Equivalent	MAGNETIC RESEARCH, INC.
K922000	MODEL #QSC-200, 20CM. QUADRATURE SHOULDER COIL	Jul 28, 1992	Substantially Equivalent	MRI DEVICES CORP.
K921881	VISTA HPQ SYSTEM	Jul 17, 1992	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K921720	MRT-50A QD SPINE COIL	Jul 16, 1992	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K920543	MRI OE 1.5 SI	Jul 10, 1992	Substantially Equivalent	OTSUKA ELECTRONICS
K920096	MRT-150 QD KNEE COIL	Jul 10, 1992	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K920789	B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER	Jun 25, 1992	Substantially Equivalent	FONAR CORP.
K920254	COILS FOR RX4000 & RX5000 MRI SYSTEMS	Jun 22, 1992	Substantially Equivalent	RESONEX, INC.
K921609	VISTA HP/HPQ SYSTEM	Jun 15, 1992	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K920098	ACCESS QD HEAD COIL	Jun 09, 1992	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K921046	BO POWER SUPPLY	May 28, 1992	Substantially Equivalent	RESONEX, INC.
K920835	PRESATURATION	May 22, 1992	Substantially Equivalent	RESONEX, INC.
K921098	MAGNETOM 63SP	May 15, 1992	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K920094	MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES	May 15, 1992	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K915567	MAGNETIC RESONANCE DIAGNOSTIC DEVICE(ACCESORY)	May 15, 1992	Substantially Equivalent	FONAR CORP.
K920095	MRT-50 MULTIVIEW COIL	Apr 28, 1992	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K920215	INSTRUMENTARIUM MEGA4 HT	Apr 14, 1992	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K920126	MRT-50 FLEXIBLE BODY COIL	Apr 06, 1992	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K920125	MRT-50 SPINE COIL	Mar 31, 1992	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K920097	MRT-50 QD HEAD COIL	Mar 31, 1992	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K915873	MOS-III	Mar 16, 1992	Substantially Equivalent	SHERMAN OPHTHALMIC SUPPLIES, INC.
K915754	16 BIT A/D	Mar 16, 1992	Substantially Equivalent	RESONEX, INC.
K915260	MRI ULTRAVIEW	Mar 16, 1992	Substantially Equivalent	A&E SPECIALTY FABRICATORS
K915657	MODIFIED MAGNETIC RESONANCE IMAGING SYTEM MOD. R28	Mar 13, 1992	Substantially Equivalent	BRUKER MEDICAL IMAGING, INC.
K920199	HEAD COIL GEOMETRIC DISTOR SPEC FOR VISTA HPQ SYST	Mar 06, 1992	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K920159	MOBILE MRP-7000	Mar 05, 1992	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K914209	MODEL 310GE-64: WHOLE VOLUME NECK COIL	Mar 05, 1992	Substantially Equivalent	MEDICAL ADVANCES, INC.
K915552	INSTRUMENTARIUM MEGA4	Feb 27, 1992	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K915579	3D PROCESSING OPTIONS FOR GYREX	Feb 18, 1992	Substantially Equivalent	ELSCINT, INC.
K915601	GYREX 2T-DLX	Feb 14, 1992	Substantially Equivalent	ELSCINT, INC.
K915598	SPECIAL PURPOSE COILS FOR GYREX V	Jan 31, 1992	Substantially Equivalent	ELSCINT, INC.
K915395	MAGNETIC RESONANE DIAGNOSTIC DEVICE ACCESSORY	Jan 23, 1992	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K913673	VECTRA MAGNETIC RESONANCE SYSTEM	Jan 23, 1992	Substantially Equivalent	GENERAL ELECTRIC CO.
K915112	MAGNETOM 42 SP,63 SP,IMPACT	Dec 27, 1991	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K913770	ADVANTAGE V.S. CT/MR RAD DIAGNOSTIC WORKSTATION	Dec 27, 1991	Substantially Equivalent	GENERAL ELECTRIC CO.
K914114	2DTOF MAGNETIC RESONANCE ANGIOGRAPH (MRA)	Dec 04, 1991	Substantially Equivalent	RESONEX, INC.
K913463	MAG RES IMAG SYST/BRUKER MODEL R28 WHOLE BODY SCAN	Nov 29, 1991	Substantially Equivalent	BRUKER MEDICAL IMAGING, INC.
K914536	MODELS 190GE-64/191GE-64/192GE-64/193GE-64	Nov 27, 1991	Substantially Equivalent	MEDICAL ADVANCES, INC.
K914535	MODEL 311GE-64: WHOLE VOLUME NECK COIL	Nov 27, 1991	Substantially Equivalent	MEDICAL ADVANCES, INC.
K914012	MRT-150A	Nov 27, 1991	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K913869	RF-OPAQUE BLANKET FOR MAGNETOM SYSTEM	Nov 25, 1991	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K914263	MRP-5000 & MRP-7000 HS/MR QUADRATURE KNEE COILS	Nov 22, 1991	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K911993	MRH-500	Nov 22, 1991	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K911872	PHILIPS RIGID VOLUME COILS	Nov 22, 1991	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K914019	MRP-5000 HS/MR QUADRATURE BODY COIL(P/N MR-QBC-31)	Nov 01, 1991	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K913325	40-140 SPIN ECHO FLOW COMPENSATED PULSE SEQUENCE	Nov 01, 1991	Substantially Equivalent	RESONEX, INC.
K913475	MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Oct 30, 1991	Substantially Equivalent	GE MEDICAL SYSTEMS
K911975	SMT-100X	Oct 30, 1991	Substantially Equivalent	SHIMADZU MEDICAL SYSTEMS
K913441	MODEL #SCT-32 AUTO QUADRATURE SPINE COIL TRANSPORT	Oct 21, 1991	Substantially Equivalent	MRI DEVICES CORP.
K912963	INSTRUMENTARIUM MEGA4	Sep 30, 1991	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K912539	SIGNA ADVANTAGE 0.5T MAGNETIC RESONANCE SYSTEM	Sep 27, 1991	Substantially Equivalent	GE MEDICAL SYSTEMS
K913534	VISTA HPQ SYSTEM	Sep 19, 1991	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K913563	MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIY	Sep 11, 1991	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K911959	SIGNA ADVANTAGE MAGNETIC RESONANCE SYSTEM M1090GF	Sep 10, 1991	Substantially Equivalent	GE MEDICAL SYSTEMS
K912881	GE MR MAX	Sep 06, 1991	Substantially Equivalent	GE MEDICAL SYSTEMS
K911746	H.I.STANDARD CALIBRE UPGRADE	Aug 16, 1991	Substantially Equivalent	HEALTH IMAGES, INC.
K912410	COXEL FLINGER 2500/5000 3-D IMAGING SYSTEM	Aug 13, 1991	Substantially Equivalent	REALITY IMAGING CORP.
K912095	MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Aug 09, 1991	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K910839	ULTIMATE 3000	Jul 26, 1991	Substantially Equivalent	FONAR CORP.
K911991	MAGNETOM P8 MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Jul 19, 1991	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K905578	VIEWNET	Jul 15, 1991	Substantially Equivalent	IMAGENET
K911800	COIL FIELD EXTENDER	Jul 03, 1991	Substantially Equivalent	RESONEX, INC.
K911806	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	Jun 28, 1991	Substantially Equivalent	GENERAL ELECTRIC CO.
K911276	MAGNETIC RESONANCE DEVICE ACCESSORY	Jun 28, 1991	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K911495	MAGNETIC RESONANCE DEVICE ACCESSORY (MRT-50A)	Jun 21, 1991	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K911348	RIGID ENDOSCOPE	Jun 21, 1991	Substantially Equivalent	BRUEL & KJAER
K911892	RX-5000 MRI SYSTEM	Jun 20, 1991	Substantially Equivalent	RESONEX, INC.
K910715	VISTA HPQ SYSTEM	Jun 07, 1991	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K911667	HITACHI MRP-7000 MAGNETIC ROSONANCE DEVICE	May 30, 1991	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K911642	MRP-5000 AND MRP-7000 MULTIPLANAR RECONSTRUCTION	May 30, 1991	Substantially Equivalent	HITACHI MEDICAL SYSTEMS AMERICA, INC.
K910802	POWER SCAN 1000	May 09, 1991	Substantially Equivalent	WEBB RESEARCH, INC.
K910817	GE QUADRATURE CERVICAL SPINE SURF COIL, M1285AR	Apr 23, 1991	Substantially Equivalent	GENERAL ELECTRIC CO.
K905634	SMT-50X	Apr 10, 1991	Substantially Equivalent	SHIMADZU MEDICAL SYSTEMS
K910269	10 ADJUSTABLE BELT COIL	Apr 08, 1991	Substantially Equivalent	RESONEX, INC.
K910498	MAGNETOM 42 SP AND 63 SP	Mar 25, 1991	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K910220	MAGNETIC RESONANCE DEVICE ACCESSORY, SM PARTS COIL	Mar 25, 1991	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K910514	MODEL 3150-21 QUADRATURE SPINE COIL IN POSITIONER	Mar 19, 1991	Substantially Equivalent	MEDICAL ADVANCES, INC.
K910513	MODEL 3150-64 QUADRATURE SPINE COIL IN POSITIONER	Mar 19, 1991	Substantially Equivalent	MEDICAL ADVANCES, INC.
K905603	PHILIPS GYROVIEW-HR IMAGING WORKSTATION	Mar 08, 1991	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K905512	ANTERIOR NECK CONTOUR COIL	Mar 07, 1991	Substantially Equivalent	MAGNETIC RESEARCH, INC.
K905833	MRP-5000(1): 2-D INFLOW MR ANGIOGRAPHY	Feb 25, 1991	Substantially Equivalent	SUMMIT WORLD TRADE CORP.
K905832	MRP -5000(1): VERSION 2.0 SOFTWARE	Feb 25, 1991	Substantially Equivalent	SUMMIT WORLD TRADE CORP.
K905835	MRP-7000: SUPPLEMENTAL R/F COILS	Feb 19, 1991	Substantially Equivalent	SUMMIT WORLD TRADE CORP.
K905834	MRP-7000(1) : 2-D INFLOW MR ANGIOGRAPHY	Feb 19, 1991	Substantially Equivalent	SUMMIT WORLD TRADE CORP.
K905366	MAGNETOM SP/AS (ACTIVELY SHIELDED)	Feb 11, 1991	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K905858	CATALOG NO. 6000-21 VOLUME NECK COIL, MODIFICATION	Feb 01, 1991	Substantially Equivalent	MEDICAL ADVANCES, INC.
K905615	MAGNETIC RESONANCE DIAG. DEV. SPECIAL PURPOSE COIL	Feb 01, 1991	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K905259	VISTA HPQ SYSTEM	Jan 24, 1991	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K905095	MODEL 3100-21: QUADRATURE SPINE COIL	Jan 11, 1991	Substantially Equivalent	MEDICAL ADVANCES, INC.
K905104	MODEL 3100-64: QUADRATURE SPINE COIL	Jan 08, 1991	Substantially Equivalent	MEDICAL ADVANCES, INC.
K905070	VISTAR	Jan 02, 1991	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K905442	MRT35-SP	Dec 21, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K905441	MRT 35-A (TM)	Dec 14, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K904528	INSTRUMENTARIUM MEGA4, MODIFICATION	Nov 20, 1990	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K904327	ADVANCED C- SPINE COIL	Nov 20, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K903770	MRT 50A	Nov 20, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K903768	MAGNETIC RESONANCE DEVICE MRT 150A	Nov 20, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K903318	MAGNETIC RESONANCE DIAGNOSTIC DEVICE MOBILE MRP-30	Nov 20, 1990	Substantially Equivalent	SUMMIT WORLD TRADE CORP.
K903661	BRUKER R-28,HEAD AND CHEST ANGIOGRAPHY IMAGING ADD	Nov 13, 1990	Substantially Equivalent	BRUKER MEDICAL IMAGING, INC.
K903755	CAT/ #4100-21 SHOULDER COIL PACKAGE, MODIFIED	Oct 26, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K903754	CAT. #4050-64 & 4065-64 SHOULDER COILS, MODIFIED	Oct 26, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K903753	CAT. #6000-21 VOLUME NECK COIL, MODIFIED	Oct 26, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K902799	GYROSCAN S15/ACS	Oct 23, 1990	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K903822	MODEL 4500-SMS-42; SHOULDER COIL	Oct 01, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K903527	MAGNETIC RESONANCE DIAGNOSTIC DEVICE-OR 41 MAGNET	Sep 27, 1990	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K902217	TEMPOROMANDIBULAR JOINT (TMJ) COIL	Sep 21, 1990	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K902663	GE QUADRATURE T/L SPINE SURF COIL, M1085AP/M1285AP	Sep 20, 1990	Substantially Equivalent	GENERAL ELECTRIC CO.
K903203	MRP-20: HS/MR HEAD COIL 3-D FT RECONSTRUCTION	Sep 17, 1990	Substantially Equivalent	SUMMIT WORLD TRADE CORP.
K903028	GYREX 2T VERSION 2.1U.	Sep 10, 1990	Substantially Equivalent	ELSCINT, INC.
K903204	MRP-20: SUPPL R/F COIL HS/MR QUADRATURE HEAD COIL	Sep 07, 1990	Substantially Equivalent	SUMMIT WORLD TRADE CORP.
K903048	VISTA MR 2055 HP SYSTEM	Aug 30, 1990	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K902933	TESLACON (MAGNETIC RESONANCE DIAGNOSTIC DEVICE)	Aug 23, 1990	Substantially Equivalent	GENERAL ELECTRIC CO.
K902044	MEGA 4 MAGNETIC RESONANCE IMAGING SYSTEM	Aug 23, 1990	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K903319	MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Aug 17, 1990	Substantially Equivalent	GE MEDICAL SYSTEMS
K901952	MAG RESON DIAG DEV ACCESS SPEC PURP REC ONLY COIL	Aug 17, 1990	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K901888	PROSTATE PROBE SURFACE COIL, CATALOG #BPX-15	Aug 10, 1990	Substantially Equivalent	MEDRAD, INC.
K902314	LARGE FLEXIBLE BODY COIL	Aug 03, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K902316	KNEE QD COIL MRT 50A	Aug 01, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K902315	CERVICAL COIL MRT 50A	Aug 01, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K902310	SOFTWARE RELEASE 4.2P, ACCESS(TM)	Aug 01, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K902630	BILATERAL TMJ COIL	Jul 19, 1990	Substantially Equivalent	RESONEX, INC.
K901730	GE SIGNA ADVANTAGE	Jul 06, 1990	Substantially Equivalent	GE MEDICAL SYSTEMS
K901980	MOBILE MRP-20 MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Jun 28, 1990	Substantially Equivalent	SUMMIT WORLD TRADE CORP.
K901864	MODEL 4050-21; 5.25 LOOP SHOULDER COIL	May 31, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K901818	ADD'L SOFTWARE VERSION D2 FOR MAGNETOM 42 AND 63	May 23, 1990	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K901639	MODEL 4050-64; 5.25 & 4065-64; 6.50 LOOP COIL	May 14, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K900919	MODIFIED HITACHI MRP-20 MAGNETIC RESONANCE DIAGNOS	May 14, 1990	Substantially Equivalent	SUMMIT WORLD TRADE CORP.
K901620	MULTIPURPOSE COIL & 3MM SLICE THICKNESS ON THE MRI	May 07, 1990	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K901602	VERSION 4.3 APPLICATION SOFTWARE FOR USE W/RX-4000	May 07, 1990	Substantially Equivalent	RESONEX, INC.
K900026	BRUKER R28 WHOLE-BODY MR SCANNER	Apr 30, 1990	Substantially Equivalent	BRUKER MEDICAL IMAGING, INC.
K901384	MODEL 6000-21; VOLUME NECK COIL	Apr 26, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K901305	MODEL 2121-21, TMJ SURFACE COIL	Apr 26, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K901242	MODEL 2121-64; TMJ SURFACE COIL	Apr 26, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K901241	THORACIC/LUMBAR SPINE 8 RACETRACK COIL, 3080-64	Apr 25, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K901092	MODEL 8010; EXTREMITY SURFACE COIL	Apr 05, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K900889	MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES	Mar 23, 1990	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K900725	RADIO FREQUENCY RECEIVER SUBSYSTEM	Mar 23, 1990	Substantially Equivalent	MYHEAL TECHNOLOGIES
K900283	MRT 50A SOFTWARE RELEASE 9.0	Mar 19, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K900728	MRT 50A KNEE COIL	Mar 09, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K900727	MRT 50A JOINT COIL	Mar 09, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K900289	MRT 50A 100MM CIRCULAR SURFACE COIL	Mar 09, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K900288	MRT 50A BRAIN QD COIL	Mar 09, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K900285	MRT 50A FLEXIBLE BODY COIL	Mar 09, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K900284	MRT 50A 150MM CIRCULAR SURFACE COIL	Mar 09, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K900064	VISTA HPQ SYSTEM, VISTA MR 2055 HP SYSTEM	Mar 09, 1990	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K895328	MAGNETIC RESONANCE SYSTEM MODEL BMT-1100	Mar 09, 1990	Substantially Equivalent	BRUKER MEDICAL IMAGING, INC.
K900287	MRT 50A CRANIO-CERVICAL COIL	Mar 08, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K900286	MRT 50A SPINE SURFACE COIL	Mar 08, 1990	Substantially Equivalent	TOSHIBA AMERICA MRI, INC.
K896419	MODEL: GYREX VERSION V	Feb 02, 1990	Substantially Equivalent	ELSCINT, INC.
K895629	MODEL 8100; UPPER EXTREMITY COIL	Feb 02, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K896789	MODEL 6000; VOLUME NECK COIL	Jan 23, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K896508	VISTA MR 2055 HP SYSTEM	Jan 12, 1990	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K896309	MAGNAVIEW M.R.I. VERSIONS 110FH & 110FM W/CARDIAC	Jan 12, 1990	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K894855	MODEL 5070; DUAL PLANAR PAIR	Jan 04, 1990	Substantially Equivalent	MEDICAL ADVANCES, INC.
K896336	MODEL SPINE SURVEYOR-PLUS; CAT. #ACS-10A	Dec 22, 1989	Substantially Equivalent	MEDICAL ADVANCES, INC.
K896647	GYROVIEW HR HIGH RESOLUTION WORKSTATION	Dec 21, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K895869	GYROSCAN T5 MOBILE	Dec 14, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS, INC.
K895966	MAGNETOM M, H, 42, 63, 42 SP AND 63 SP	Nov 30, 1989	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K894016	MAGNETIC RESONANCE DIAGNOSTIC DEVICE MRP-20	Nov 22, 1989	Substantially Equivalent	SUMMIT WORLD TRADE CORP.
K895794	GE MR MAX SYSTEM	Nov 17, 1989	Substantially Equivalent	GE MEDICAL SYSTEMS
K894714	1989 SOFTWARE REVISION TO THE BMT-1100	Nov 15, 1989	Substantially Equivalent	BRUKER MEDICAL IMAGING, INC.
K893744	SMT-50A MAGNETIC RESONANCE IMAGING SYSTEM	Nov 06, 1989	Substantially Equivalent	SHIMADZU MEDICAL SYSTEMS
K895151	VISTA MR 2055 HP SYSTEM	Oct 30, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K895131	MODEL 2031 TMJ SURFACE COIL	Oct 27, 1989	Substantially Equivalent	MEDICAL ADVANCES, INC.
K893518	MT/S SOFTWARE RELEASE 5.0.	Oct 27, 1989	Substantially Equivalent	DIASONICS, INC.
K895221	ADD'L OPTIONS 1.5 TESLA & 1.0 TESLA TO MAGNETOM 42	Oct 03, 1989	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K894974	MOBILE RX-4000 MAGNETIC RESONANCE IMAGING SYSTEM	Sep 12, 1989	Substantially Equivalent	RESONEX, INC.
K894290	ACCESS TM	Sep 07, 1989	Substantially Equivalent	DIASONICS, INC.
K893509	GE SIGNA ADVANTAGE	Aug 11, 1989	Substantially Equivalent	GE MEDICAL SYSTEMS
K893750	MRT-50A MOBILE	Aug 09, 1989	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS
K893640	SOFTWARE VERSION, D1.3 AND A1.3 FOR MAGNETOM	Aug 02, 1989	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K893689	VISION INTEGRATED PERFORMANCE OPTION	Jul 20, 1989	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K893739	VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES	Jul 14, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K893675	VISTA MR 2055 HP SYSTEM AND 2055 UPGRADES	Jul 14, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K893881	ACCESS TM	Jun 23, 1989	Substantially Equivalent	DIASONICS, INC.
K893619	VISTA MR 2055 HP SYSTEM	Jun 23, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K891760	MAGNETIC RESONANCE SYSTEM, MODEL BMT 1100,MODIFIED	Jun 23, 1989	Substantially Equivalent	BRUKER MEDICAL IMAGING, INC.
K891543	MAGNAVIEW MOBILE MRI VERSION 110 FHM	Jun 23, 1989	Substantially Equivalent	INSTRUMENTARIUM IMAGING, INC.
K890092	HI STANDARD MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Jun 23, 1989	Substantially Equivalent	HEALTH IMAGES, INC.
K891769	MAGNISCAN 5000 MR SYSTEM	Jun 15, 1989	Substantially Equivalent	GENERAL ELECTRIC CO.
K892959	VERSION 4.2 APPLICATION SOFTWARE	Jun 01, 1989	Substantially Equivalent	RESONEX, INC.
K892235	GE SHOULDER SURFACE COIL, CAT. #M1085AN	May 11, 1989	Substantially Equivalent	GENERAL ELECTRIC CO.
K891598	MODEL 2030; 3 TMJ SURFACE COIL	May 11, 1989	Substantially Equivalent	MEDICAL ADVANCES, INC.
K891541	MAGNETIC RESONANCE DEVICE ACCESSORY SOFTWARE 4.0.	May 11, 1989	Substantially Equivalent	DIASONICS, INC.
K890855	MODEL 4041; 4 ANGLED PAIR CRC SURFACE COIL	May 01, 1989	Substantially Equivalent	MEDICAL ADVANCES, INC.
K890789	GYROSCAN T5 MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Apr 28, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
K890666	MODEL 3031; CERVICAL SPINE SURFACE COIL	Apr 14, 1989	Substantially Equivalent	MEDICAL ADVANCES, INC.
K890815	MAGNETIC RESONANCE DIAGNOSTIC DEVICE ACCESSORIES	Apr 03, 1989	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K890394	MEDRAD SCPD 1000	Mar 14, 1989	Substantially Equivalent	MEDRAD, INC.
K885047	VISTA MR 2055 HP SYSTEM	Mar 14, 1989	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K885223	RMI SHORT DISTANCE ALIGNMENT DEVICE	Feb 17, 1989	Substantially Equivalent	RADIATION MEASUREMENTS, INC.
K884816	ACCESS(TM) MAGNETIC RESONANCE DEVICE ACCESSORY	Feb 02, 1989	Substantially Equivalent	DIASONICS, INC.
K883898	MAGNETOM 42 SP AND MAGNETOM 63 SP	Jan 24, 1989	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K884484	MAGNETIC RESONANCE DIAGNOSTIC HELMHOLTZ NECK COIL	Jan 17, 1989	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K884607	MT/S (SOFTWARE RELEASE 3.1)	Dec 21, 1988	Substantially Equivalent	DIASONICS, INC.
K884743	TEMPOROMANDIBULAR JOINT COIL (TMJ)	Dec 05, 1988	Substantially Equivalent	DIASONICS, INC.
K884606	MT/S (SPINE TRANSMIT COIL)	Dec 05, 1988	Substantially Equivalent	DIASONICS, INC.
K884604	MT/S CARLSON SPINE COIL, PART # 100-50082500-01	Nov 30, 1988	Substantially Equivalent	DIASONICS, INC.
K884603	SHOULDER TRANSMIT AND RECEIVE COILS	Nov 30, 1988	Substantially Equivalent	DIASONICS, INC.
K883547	GE MR MAX SYSTEM	Nov 30, 1988	Substantially Equivalent	GENERAL ELECTRIC CO.
K884369	POSTERIOR CERVICAL SPINE SURFACE COIL M1085AM	Nov 28, 1988	Substantially Equivalent	GENERAL ELECTRIC CO.
K884062	MAGNETOM (M, H, 42, 63) SEQUENCES	Nov 23, 1988	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K883994	VISTA MR 2055 HP SYSTEM	Nov 21, 1988	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K883872	CP HEAD COIL & 260MM (CV) TRANSMIT-RECEIVE COIL	Nov 21, 1988	Substantially Equivalent	SIEMENS MEDICAL SOLUTIONS USA, INC.
K883756	TOSHIBA MRT-50A MAGNETIC RESONANCE SYSTEM	Nov 14, 1988	Substantially Equivalent	TOSHIBA MEDICAL SYSTEMS
K883621	INSTRUMENTARIUM ULF MR IMAGING SYSTEM	Nov 10, 1988	Substantially Equivalent	INSTRUMENTARIUM CORP.
K883699	B3000/B3000M MAGNETIC RESONANCE IMAGING SCANNER	Oct 31, 1988	Substantially Equivalent	FONAR CORP.
K883649	INSTRUMENTARIUM ULF MR IMAGING SYSTEM MODEL 110H	Oct 19, 1988	Substantially Equivalent	INSTRUMENTARIUM CORP.
K883648	BETA 3000M MOBILE NMR IMAGING SYSTEM	Oct 19, 1988	Substantially Equivalent	FONAR CORP.
K883519	FAST AND CE-FAST MRI SEQUENCES (FOR NMR 1000)	Oct 19, 1988	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K883482	VISTA MR 2055 HP SYSTEM	Oct 19, 1988	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K883737	VFQ HEAD COIL	Oct 13, 1988	Substantially Equivalent	RESONEX, INC.
K883520	0.5 T COMPACT MAGNET FOR ITS VISTA MR 2055 HP SYST	Oct 07, 1988	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K883516	DIASONICS MT/P IMAGING SYSTEM	Oct 07, 1988	Substantially Equivalent	DIASONICS, INC.
K883378	VISTA MR 2055 HP SYSTEM	Sep 22, 1988	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
K883650	INSTRUMENTARIUM ULF MR IMAGING SYSTEM VERSION 110	Sep 16, 1988	Substantially Equivalent	INSTRUMENTARIUM CORP.
K883622	INSTRUMENTARIUM ULF MR IMAGING SYSTEM	Sep 14, 1988	Substantially Equivalent	INSTRUMENTARIUM CORP.
K883521	C/R GATING FOR ITS VISTA MR 2055/2055 UP & HP SYS	Sep 02, 1988	Substantially Equivalent	PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.

FEI Numbers

This FDA classification entry is associated with 152 FEI numbers. Click on an entry to view related FDA registrations.

1000113348: 1 registration

1000114111: 152 registrations

1000138054: 760 registrations

1000143606: 30 registrations

1000158431: 16 registrations

1000208827: 16 registrations

1000219637: 355 registrations

1000284313: 125 registrations

1000306474: 1 registration

1000403400: 19 registrations

1000517638: 102 registrations

1000571342: 25 registrations

1038814: 23 registrations

1051786: 7 registrations

1221108: 11 registrations

1526534: 933 registrations

1721113: 4 registrations

1826555: 34 registrations

1937223: 27 registrations

2011171: 834 registrations

2126677: 69 registrations

2183553: 71 registrations

2432211: 7 registrations

2520313: 49 registrations

3000126629: 658 registrations

3001654007: 64 registrations

3001814065: 7 registrations

3002806900: 3 registrations

3002806926: 9 registrations

3002807880: 255 registrations

3002808157: 141 registrations

3002808382: 216 registrations

3003186357: 10 registrations

3003190524: 99 registrations

3003377038: 27 registrations

3003494057: 1 registration

3003575350: 9 registrations

3003661577: 8 registrations

3004116362: 2 registrations

3004526608: 19 registrations

3004531751: 4 registrations

3004754211: 49 registrations

3004859018: 5 registrations

3004929307: 17 registrations

3004977335: 291 registrations

3004994584: 2 registrations

3005049692: 6 registrations

3005214683: 63 registrations

3005326970: 36 registrations

3005450718: 8 registrations

3005517190: 3 registrations

3005810333: 50 registrations

3005877899: 47 registrations

3006015847: 1 registration

3006073271: 3 registrations

3006239787: 7 registrations

3006262888: 7 registrations

3006369484: 20 registrations

3006621332: 8 registrations

3006738448: 6 registrations

3007350713: 40 registrations

3007545404: 26 registrations

3007546534: 1 registration

3007556128: 12 registrations

3007562060: 13 registrations

3007734888: 57 registrations

3008114978: 4 registrations

3008156140: 1 registration

3008284470: 75 registrations

3008298501: 5 registrations

3008355361: 33 registrations

3008447096: 1 registration

3008496839: 60 registrations

3008632256: 13 registrations

3008986341: 5 registrations

3009077524: 178 registrations

3009154005: 2 registrations

3009196578: 99 registrations

3009504230: 43 registrations

3009617712: 165 registrations

3009714754: 4 registrations

3009715136: 17 registrations

3009755250: 9 registrations

3009882464: 76 registrations

3009963139: 8 registrations

3010009632: 31 registrations

3010326005: 24 registrations

3010398867: 27 registrations

3010701021: 5 registrations

3010703925: 45 registrations

3010949642: 37 registrations

3011015597: 58 registrations

3011106828: 17 registrations

3011165593: 18 registrations

3011416394: 99 registrations

3011657336: 1 registration

3011767965: 1 registration

3012075008: 14 registrations

3012127758: 23 registrations

3012354318: 1 registration

3012439308: 9 registrations

3012939903: 19 registrations

3013679558: 7 registrations

3013695852: 3 registrations

3013875850: 5 registrations

3014111222: 8 registrations

3014232555: 8 registrations

3014310698: 15 registrations

3014343100: 4 registrations

3014635027: 1 registration

3014680716: 2 registrations

3014809646: 17 registrations

3015232217: 97 registrations

3015276088: 90 registrations

3015329423: 28 registrations

3015425142: 9 registrations

3015431711: 9 registrations

3015534535: 1 registration

3015872432: 7 registrations

3016591365: 1 registration

3016727312: 5 registrations

3016851825: 61 registrations

3016998660: 3 registrations

3017297314: 1 registration

3017375271: 31 registrations

3017383732: 1 registration

3017772876: 33 registrations

3018004899: 8 registrations

3018423337: 31 registrations

3019595609: 1 registration

3019844073: 2 registrations

3020162557: 1 registration

3020870877: 2 registrations

3021059265: 12 registrations

3021593788: 1 registration

3023003446: 73 registrations

3023385454: 12 registrations

3026047529: 9 registrations

3026391023: 4 registrations

3027325776: 1 registration

3027339477: 14 registrations

3029521953: 8 registrations

3030982377: 1 registration

3031503890: 73 registrations

3032109225: 63 registrations

3033333119: 1 registration

3033524194: 1 registration

3033527281: 28 registrations

3033536331: 1 registration

3034286426: 27 registrations

3036666444: 14 registrations

3038319253: 2 registrations