Product Code: MOS FDA class 2 21 CFR 892.1000

Coil, Magnetic Resonance, Specialty

Radiology

The Specialty Magnetic Resonance Coil is a radiology device used as a component of MRI systems to improve signal reception from specific anatomical regions, enabling higher quality imaging of targeted areas such as the spine, extremities, or head. Classified as FDA Class 2 under 21 CFR 892.1000 in the Radiology specialty, it requires 510(k) premarket notification. The product code is MOS, and it is eligible for third-party 510(k) review.

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510(k)s

488

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: MOS
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 488 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K260947	0.55T 12Ch Breast Coil	Apr 23, 2026	Substantially Equivalent	Neocoil, LLC
K252587	HD 8Ch Wrist Array	Apr 14, 2026	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K252876	GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive Only; GEM Flex Coil 16-S Array, 3.0T Receive Only	Apr 01, 2026	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K260519	Smart Fit TorsoCardiac 1.5T	Mar 20, 2026	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.
K252179	GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive Only; GEM Flex Coil 16-S Array, 1.5T Receive Only	Feb 10, 2026	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K253738	3.0T AIR 32CH HNA	Jan 23, 2026	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K254190	dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T	Jan 14, 2026	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K253182	InkSpace Imaging Small Body Array (SBA12PH30x)	Oct 20, 2025	Substantially Equivalent	Inkspace Imaging, Inc.
K243428	e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector	Jul 17, 2025	Substantially Equivalent	Dxtx Medical, Inc.
K244054	16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)	Feb 28, 2025	Substantially Equivalent	Quality Electrodynamics
K243675	InkSpace Imaging Small Body Array	Dec 20, 2024	Substantially Equivalent	Inkspace Imaging, Inc.
K243316	XENOVIEW 3.0T Chest Coil	Nov 19, 2024	Substantially Equivalent	Polarean, Inc.
K243033	dS Wrist coil 8ch 1.5T	Oct 18, 2024	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K242879	dS Knee Coil 8ch 1.5T	Oct 18, 2024	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K242096	dS FootAnkle Coil 8ch 1.5T	Aug 12, 2024	Substantially Equivalent	Philips Medical Systems Nederland B.V.
K241069	iLoop Interventional Coil 0.55T	Jun 07, 2024	Substantially Equivalent	Noras Mri Products GmbH
K233652	Contour Hand/Wrist (Q7000232)	Feb 16, 2024	Substantially Equivalent	Quality Electrodynamics
K233656	Contour Shoulder	Feb 15, 2024	Substantially Equivalent	Quality Electrodynamics
K233600	Smart Fit Knee 3.0T	Feb 05, 2024	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.
K233444	InkSpace Imaging Small Body Array	Jan 08, 2024	Substantially Equivalent	Inkspace Imaging, Inc.
K233348	16 Breast Coil	Oct 24, 2023	Substantially Equivalent	Philips Medical System Nederlands B.V.
K232762	dS Breast Coil 7ch 1.5T	Oct 03, 2023	Substantially Equivalent	Invivo Corporation (Business Trade Name: Philips)
K232021	Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T	Sep 01, 2023	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.
K231085	1.5T HD T/R Knee Array (10-F34127)	Aug 18, 2023	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K223484	IGAR System (1001.A)	Jul 20, 2023	Substantially Equivalent	Insight Medbotics, Inc.
K231647	XENOVIEW 3.0T Chest Coil	Jun 29, 2023	Substantially Equivalent	Polarean, Inc.
K223225	8ch T/R Knee Coil	Feb 14, 2023	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K213480	31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil	Feb 01, 2023	Substantially Equivalent	Rapid Biomedical GmbH
K223429	Contour Knee	Jan 13, 2023	Substantially Equivalent	Quality Electrodynamics, LLC
K223378	3.0T 16ch AIR AA	Jan 03, 2023	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K212239	XENOVIEW 3.0T Chest Coil	Dec 23, 2022	Substantially Equivalent	Polarean, Inc.
K223487	InkSpace Imaging Body Array	Dec 08, 2022	Substantially Equivalent	Inkspace Imaging, Inc.
K223239	8ch Wrist Coil	Dec 08, 2022	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K222407	16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breast Coil	Oct 14, 2022	Substantially Equivalent	Neocoil, LLC
K222325	8ch Wrist Coil	Aug 31, 2022	Substantially Equivalent	Invivo Corporation (Business Trade Name: Philips)
K222257	1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil	Aug 23, 2022	Substantially Equivalent	Invivo Corporation (Business Trade Name: Philips)
K213735	dS Sentinelle Breast 16ch 1.5T Coil	Aug 08, 2022	Substantially Equivalent	Invivo Corporation (Business Trade Name: Philips)
K213727	dS Sentinelle Breast 16ch 3.0T Coil	Aug 08, 2022	Substantially Equivalent	Invivo Corporation (Business Trade Name: Philips)
K220144	Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T	Apr 08, 2022	Substantially Equivalent	Noras Mri Products GmbH
K213687	32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open Neck Chest Anterior 7ch / 3.0T AIR Open Neck Chest Anterior 7ch, 1.5T AIR Open Head Anterior 16ch / 3.0T AIR Open Head Anterior 16ch	Mar 11, 2022	Substantially Equivalent	Neocoil, LLC
K211658	OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY with HeadCoilSet Philips 1.5T, OR Head Holder LUCY with HeadCoilSet Philips 3T	Mar 03, 2022	Substantially Equivalent	Noras Mri Products GmbH
K213766	dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coils for 1.5T and 3.0T	Dec 23, 2021	Substantially Equivalent	Invivo Corporation
K213397	InkSpace Imaging Pediatric Body Array	Dec 17, 2021	Substantially Equivalent	Inkspace Imaging, Inc.
K212864	dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T	Dec 01, 2021	Substantially Equivalent	Philips Healthcare (Suzhou) Co., Ltd.
K213351	ds Head 32ch 3.0T	Oct 29, 2021	Substantially Equivalent	Invivo Corporation (Business Trade Name: Philips)
K200836	8ch Flex Suite	Jul 22, 2020	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K201101	1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil	Jun 02, 2020	Substantially Equivalent	Neocoil, LLC
K200477	Flex Body Speeder	Apr 08, 2020	Substantially Equivalent	Quality Electrodynamics, LLC
K191539	1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support	Jan 31, 2020	Substantially Equivalent	Rapid Biomedical GmbH
K193140	Flex Body SPEEDER	Jan 03, 2020	Substantially Equivalent	Quality Electrodynamics, LLC
K190668	Encompass 15 Channel Head Coil, 3T	Sep 09, 2019	Substantially Equivalent	Qfix
K182737	3T 32 Channel Head Coil	Apr 12, 2019	Substantially Equivalent	Nova Medical, Inc.
K183186	Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4, Infant Coil 24, Cardiac Coil 24, Foot & Ankle Coil - 24	Feb 08, 2019	Substantially Equivalent	Shanghai United Imaging Healthcare Co., Ltd.
K183111	Contour 24	Dec 07, 2018	Substantially Equivalent	Quality Electrodynamics, LLC
K182958	1.5T 16ch Breast Coil	Nov 16, 2018	Substantially Equivalent	Neocoil, LLC
K181948	1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil	Nov 16, 2018	Substantially Equivalent	Rapid Biomedical GmbH
K182590	1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA	Oct 19, 2018	Substantially Equivalent	GE Healthcare
K182504	3.0T Air MP M, 3.0T Air MP L	Oct 12, 2018	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K181697	16ch Foot/ Ankle SPEEDER	Jul 11, 2018	Substantially Equivalent	Quality Electrodynamics, LLC
K180666	48CH Head Coil	Apr 12, 2018	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K163661	P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil	Mar 21, 2018	Substantially Equivalent	Rapid Biomedical GmbH
K180123	Breast BI 7 MR Coil 1.5T Mammavention	Feb 16, 2018	Substantially Equivalent	Noras Mri Products GmbH
K173469	16ch T/R Hand Wrist Coil	Jan 09, 2018	Substantially Equivalent	Quality Electrodynamics, LLC
K172222	8ch Flex Suite	Dec 08, 2017	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K173377	3.0T 16ch Breast Coil	Nov 28, 2017	Substantially Equivalent	Neocoil, LLC
K173290	DuoFLEX Coil Suite	Nov 28, 2017	Substantially Equivalent	Mr Instruments, Inc.
K172695	AIR Anterior Array, AIR Posterior Array	Nov 22, 2017	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K173446	Contour 24	Nov 17, 2017	Substantially Equivalent	Quality Electrodynamics, LLC
K171515	NHAC 16	Jul 26, 2017	Substantially Equivalent	Lmt Medical Systems GmbH
K162651	Breast BI 7 MR Coil Mammavention 3T	Jan 18, 2017	Substantially Equivalent	Moras Mri Products GmbH
K163205	48CH Head Coil	Jan 12, 2017	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K162946	8ch Knee-Foot SPEEDER	Jan 06, 2017	Substantially Equivalent	Quality Electrodynamics, LLC
K162623	16ch T/R Hand Wrist Coil	Dec 09, 2016	Substantially Equivalent	Quality Electrodynamics, LLC
K162966	TxRx Knee 15 Flare MR Coil 1.5T	Nov 30, 2016	Substantially Equivalent	Quality Electrodynamics, LLC
K163066	TxRx Knee 15 Flare MR Coil 3.0T	Nov 29, 2016	Substantially Equivalent	Quality Electrodynamics, LLC
K162863	dS Small Extremity 16CH 1.5T Coil	Nov 07, 2016	Substantially Equivalent	Invivo Therapeutics Corporation
K162029	16ch T/R Knee Coil	Oct 18, 2016	Substantially Equivalent	Quality Electrodynamics, LLC
K162079	TRILLIUM Oval Head Coil 32	Sep 16, 2016	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K162177	dS FootAnkle I6CH 1.5T Coil	Sep 14, 2016	Substantially Equivalent	Invivo Corporation
K162001	1.5T and 3.0T 16 CH GE Shoulder Coils	Aug 31, 2016	Substantially Equivalent	Invivo Corporation
K160932	8ch Foot Ankle Coil	Aug 01, 2016	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K160935	8ch Foot Ankle Coil	Jul 28, 2016	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K161193	16ch Tx/Rx Knee SPEEDER	Jun 02, 2016	Substantially Equivalent	Quality Electrodynamics, LLC
K152695	8 CH Knee SPEEDER	Nov 18, 2015	Substantially Equivalent	Quality Electrodynamics, LLC
K151753	16 ch Tx/Rx Knee SPEEDER	Aug 27, 2015	Substantially Equivalent	Quality Electrodynamics, LLC
K151653	8ch Foot Ankle Coil	Aug 07, 2015	Substantially Equivalent	Shenzhen RF Tech Co., Ltd.
K151829	Atlas SPEEDER Header/Neck	Jul 29, 2015	Substantially Equivalent	Quality Electrodynamics, LLC
K150331	18ch T/R Knee Coil	Apr 09, 2015	Substantially Equivalent	Quality Electrodynamics, LLC
K143389	3.0T GEM RT Open Array	Mar 06, 2015	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K142676	Siemens 3.0T PROCURE Array Coil	Dec 05, 2014	Substantially Equivalent	Resonance Innovations, LLC
K142802	Atlas SPEEDER Head/Neck	Nov 24, 2014	Substantially Equivalent	Quality Electrodynamics, LLC
K142755	Siemens 3.0 Blanket Array Coil	Oct 23, 2014	Substantially Equivalent	Resonance Innovations, LLC
K142002	BREAST SPEEDER CX, GRID HOLDER CX	Aug 22, 2014	Substantially Equivalent	Quality Electrodynamics, LLC
K133506	NORAS OR HEAD HOLDER FLEXIBILITY	Aug 06, 2014	Substantially Equivalent	Noras Mri Products GmbH
K141832	3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE	Jul 31, 2014	Substantially Equivalent	Neocoil, LLC
K140998	PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL	Jul 11, 2014	Substantially Equivalent	Quality Electrodynamics, LLC
K140606	1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL	May 12, 2014	Substantially Equivalent	Resonance Innovations, LLC
K140252	16 CH MULTIPURPOSE COIL VARIETY	May 08, 2014	Substantially Equivalent	Noras Rontgen-Und Medizintechnik GmbH
K140282	ST SENSE NV 8 ARRAY COIL	Feb 26, 2014	Substantially Equivalent	Resonance Innovations, LLC
K133986	1.5T ORBIT AND MANDIBLE ARRAY, 3.0T ORBIT AND MANDIBLE ARRAY	Jan 27, 2014	Substantially Equivalent	Resonance Innovations, LLC
K132444	ATAMA SYSTEM	Jan 27, 2014	Substantially Equivalent	Monteris Medical,
K133422	1.5T 16-CHANNEL FLEX COIL, SMALL 1.5T 16-CHANNEL FLEX COIL, LARGE	Dec 26, 2013	Substantially Equivalent	Neocoil, LLC
K130706	DUOFLEX COIL SUITE (1.5T)	Jul 25, 2013	Substantially Equivalent	Mr Instruments, Inc.
K130457	3T DISTAL COIL, 3T ELBOW COIL, 3T LONG BONE COIL	May 20, 2013	Substantially Equivalent	Resonance Innovations, LLC
K123708	SPINE COIL	Apr 10, 2013	Substantially Equivalent	Usa Paramed Medical Systems, Inc.
K123272	1.5T 16CH FLEX SPEEDER LARGE, 1.5T 16CH FLEX SPEEDER MEDIUM	Mar 28, 2013	Substantially Equivalent	Neocoil, LLC
K123681	1.5T 4CH LARGE FLEX COIL, 1.5 4CH SMALL FLEX COIL	Feb 22, 2013	Substantially Equivalent	Wipro GE Healthcare Private, Ltd.
K123327	1.5T GEM RT OPEN ARRAY	Jan 11, 2013	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K123091	VISIUS WIRELESS COILS, 1.5T/ VISIUS WIRELESS COILS, 3T	Dec 27, 2012	Substantially Equivalent	Imris, Inc.
K122897	SENSE HEAD 16 MODEL 800647, SENSE SPINE 16 MODEL 800646; SENSE TORSO 16 MODEL 800645	Dec 21, 2012	Substantially Equivalent	Invivo Corporation
K123492	DS ANTERIOR, DS BASE, DS HEAD-NECK, DS HEAD, FLEX (S,M,L)	Dec 13, 2012	Substantially Equivalent	Philips Medical Systems
K122646	DS BREAST 16CH I/T 1.5T DS BREAST 16CH I/T 3.0T	Nov 02, 2012	Substantially Equivalent	Invivo Corporation
K122694	GE 8CH FOOT ANKLE COIL	Oct 25, 2012	Substantially Equivalent	Ge Hangwei Medical Systems Co., Ltd.
K122638	TOSHIBA 3T 32CH HEAD SPEEDER COIL,	Sep 25, 2012	Substantially Equivalent	Quality Electrodynamics
K121911	OCTAVE SPEEDER SPINE	Aug 17, 2012	Substantially Equivalent	Toshiba Medical Systems Corporation, Japan
K121910	OCTAVE SPEEDER HEAD	Aug 17, 2012	Substantially Equivalent	Toshiba Medical Systems Corporation, Japan
K121362	1.5T 16CH FLEX SPEEDER LARGE	Jun 15, 2012	Substantially Equivalent	Neocoil, LLC
K121249	MULTIARRAY KIT	Jun 12, 2012	Substantially Equivalent	Paramed S.R.L.
K120627	TOSHIBA 1.5T QD HEAD COIL	Mar 29, 2012	Substantially Equivalent	Quality Electrodynamics
K113365	INFANT ARRAY	Mar 29, 2012	Substantially Equivalent	Advanced Imaging Research Dba Sree Medical Systems
K113474	1.5T GEM FLEX COIL	Mar 16, 2012	Substantially Equivalent	Neocoil, LLC
K120290	TOSHIBA 1.5T CARDIAC COIL	Feb 28, 2012	Substantially Equivalent	Quality Electrodynamics
K120122	SENSE MSK S 8CH 1.5T	Feb 10, 2012	Substantially Equivalent	Invivo Corporation
K111673	1.5T AND 3T 8-CHANNEL MEDIUM GENERAL PURPOSE FLEX COIL	Dec 23, 2011	Substantially Equivalent	Invivo Corporation
K113280	CAROTID COIL GE 1.5T	Nov 23, 2011	Substantially Equivalent	Tursiop Technologies, LLC
K112002	CAROTID COIL	Nov 18, 2011	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.
K112293	HTS EXTREMITY COIL, HTS SURFACE COIL	Sep 30, 2011	Substantially Equivalent	Time Medical Systems, Inc.
K112366	4CH FLEX SPEEDER	Sep 15, 2011	Substantially Equivalent	Toshiba Medical Systems Coporation, Japan
K112313	TOSHIBA 3T EXTRA LARGE KNEE COIL	Sep 09, 2011	Substantially Equivalent	Quality Electrodynamics
K111060	MRGFUS PELVIC PA COIL MODEL 1.0	Sep 09, 2011	Substantially Equivalent	Insightech, Ltd.
K111802	SV BRAIN ARRAY, SIEMENS 3T	Sep 08, 2011	Substantially Equivalent	Mri Interventions, Inc.
K112112	SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS	Aug 25, 2011	Substantially Equivalent	Sentinel Medical, Inc.
K103274	SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING	Aug 18, 2011	Substantially Equivalent	Sentinelle Medical, Inc.
K111259	SV DBS VRAIN ARRAY	Jul 05, 2011	Substantially Equivalent	Midwest Rf, LLC
K111251	4CH FLEX SPEEDER	May 27, 2011	Substantially Equivalent	Toshiba Medical Systems Coporation, Japan
K102748	31P/1H HEAD COIL 3T; 23NA/1H HEAD COIL 3T; 13C/1H HEAD COIL 3T	May 13, 2011	Substantially Equivalent	Rapid Biomedical GmbH
K110487	FLEXIBLE CARDIAC COIL	Apr 19, 2011	Substantially Equivalent	Lbds Holding Company
K110411	ATAMA SYSTEM	Apr 08, 2011	Substantially Equivalent	Monteris Medical, Inc.
K110373	TEMPOROMANIBULAR COIL 15	Apr 06, 2011	Substantially Equivalent	Esaote, S.p.A.
K110610	1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL	Apr 01, 2011	Substantially Equivalent	Ge Medical Systems, LLC
K110591	MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL HEAD COIL	Mar 29, 2011	Substantially Equivalent	Mr Instruments, Inc.
K103335	GEM OPTION FOR 1.5 MRI SYSTEMS	Mar 07, 2011	Substantially Equivalent	GE Healthcare
K110120	ECHELON RAPID CARDIAC COIL	Feb 25, 2011	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K103185	TOSHIBA 1.5T EXTRA LARGE KNEE COIL	Feb 25, 2011	Substantially Equivalent	Quality Electrodynamics
K103506	1.5T HEAD COIL (HC150), 3T HEAD COIL (HC300)	Feb 02, 2011	Substantially Equivalent	Imris, Inc.
K103365	DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A	Jan 12, 2011	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K103275	SPECIALTY COILS FOR MAGNETOM AERA 1.5T & MAGNETIM SKYRA 3T MR SYSTEMS	Jan 11, 2011	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K103149	1.5T 16-CHANNEL HAND-WRIST COIL	Jan 03, 2011	Substantially Equivalent	Invivo Corporation
K103342	3.0T METAFLEXCOIL	Dec 23, 2010	Substantially Equivalent	Neocoil, LLC
K102348	31P/1H DUAL TUNED SURFACE COIL 3T; 23NA/ 1H DUAL TURNED SURFACE COIL 3T; 13C /1H DUAL TURNED SURFACE COIL 3T	Dec 22, 2010	Substantially Equivalent	Rapid Biomedical GmbH
K102889	HITACHI ECHELON NV ATTACHMENT AND SMALL EXTREMITY COILS MODEL ECHELON	Dec 20, 2010	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K093689	1.5 TESLA 16- CHANNEL RECEIVE-ONLY PHASED- ARRAY HEAD COIL FOR SIEMANS	Aug 31, 2010	Substantially Equivalent	Mr Medical Solutions, LLC
K100141	14-CHANNEL EXTREMITY COIL FOR MAGNETOM ESSENZA	Aug 27, 2010	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K101632	METAFLEXCOIL	Aug 24, 2010	Substantially Equivalent	Neocoil, LLC
K091047	NEONATE ARRAY COILS	Aug 18, 2010	Substantially Equivalent	Lmt Medical Systems GmbH
K101949	PEDIATRIC BODY-CARDIAC COIL, MODEL: 5000012601	Jul 28, 2010	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.
K101858	PEDIATRIC HEAD-SPINE COIL (MODEL:5000012701	Jul 14, 2010	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.
K101492	8 CHANNEL CARDIAC PHASED ARRAY COIL	Jun 23, 2010	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K100113	VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51	Apr 22, 2010	Substantially Equivalent	Sentinelle Medical, Inc.
K100670	S-SCAN, MODEL 9800020010	Apr 05, 2010	Substantially Equivalent	Esaote, S.p.A.
K093842	1.5T AND 3.0T GENERAL PURPOSE FLEX COILS	Mar 05, 2010	Substantially Equivalent	Invivo Corporation
K093284	1.0T 8-CHANNEL PANORAMA BREAST ARRAY COIL	Feb 01, 2010	Substantially Equivalent	Invivo Corporation
K093667	SHOULDER SPEEDER COIL	Jan 28, 2010	Substantially Equivalent	Quality Electrodynamics
K093693	NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH	Jan 19, 2010	Substantially Equivalent	Noras Mri Products GmbH
K093348	3.0T 16 CHANNEL HEAD NECK SPINE COIL	Nov 25, 2009	Substantially Equivalent	Ge Healthcare Coils (Usa Instruments, Inc.)
K092962	CAROTID COIL 5000004901	Oct 09, 2009	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.
K091902	1.5T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800494, 3.0T 8-CHANNEL SMALL EXTREMITY COIL, MODEL 800484	Aug 21, 2009	Substantially Equivalent	Invivo
K091546	NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230	Jun 24, 2009	Substantially Equivalent	Noras Mri Products GmbH
K091114	TXRX 1.5T CP HEAD COIL; TXRX 3T CP HEAD COIL	May 01, 2009	Substantially Equivalent	Quality Electrodynamics
K083539	INFANT CARDIAC ARRAY	Apr 03, 2009	Substantially Equivalent	Advanced Imaging Research, Inc.
K090267	SV DBS BRAIN ARRAY, MODEL 1500SV-SMS64	Mar 16, 2009	Substantially Equivalent	Midwest Rf, LLC
K083541	NEONATE HEAD AND BODY COILS	Feb 24, 2009	Substantially Equivalent	Advanced Imaging Research, Inc.
K083578	NORAS CPC MULTIFUNCTIONAL COIL	Jan 16, 2009	Substantially Equivalent	Noras Mri Products GmbH
K083166	SPECIALTY COILS FOR THE MAGNETOM ESSENZA	Jan 13, 2009	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K083434	TT1 GENERAL PURPOSE COIL	Dec 23, 2008	Substantially Equivalent	Tursiop Technologies, LLC
K083086	ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)	Dec 05, 2008	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K083255	16CH AI BREAST COILS 1.5 T AND 3 T	Nov 21, 2008	Substantially Equivalent	Rapid Biomedical GmbH
K083160	1.5T ATLAS SPEEDER HEAD-NECK COIL	Nov 07, 2008	Substantially Equivalent	Quality Electrodynamics
K082987	HRK-63-16 KNEE ARRAY COIL, HRK-127-16 KNEE ARRAY COIL	Nov 06, 2008	Substantially Equivalent	Invivo
K083014	ATLAS SPEEDER HEAD/CERVICAL COIL, MODEL MJAH-137A	Oct 17, 2008	Substantially Equivalent	Toshiba America Medical Systems, In.C
K082916	HRB-127-32 HIGH RESOLUTION BRAIN COIL	Oct 15, 2008	Substantially Equivalent	Invivo
K082636	TXRX 15CH KNEE COIL (1.5T AND 3T), TXRX CP EXTREMITY COIL 3T	Sep 25, 2008	Substantially Equivalent	Quality Electrodynamics
K082373	NORAS MR-BI320-PA 3T	Aug 29, 2008	Substantially Equivalent	Noras Mri Products GmbH
K081745	ECHELON RAPID PV COIL, MODEL MR-PVC-150, ECHELON RAPID FOOT COIL, MODEL MR-RFC-150 AND ECHELON RAPID KNEE COIL	Aug 12, 2008	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K081340	PEDIATRIC BODY AND CARDIAC COIL, MODEL 01000140201	Jun 18, 2008	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.
K081322	MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL 0100140201, PEDIATRIC HEAD-SPINE COIL	Jun 18, 2008	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.
K081198	ECHELON RAPID HEAD COIL, MODEL MR-RHC-150N, ECHELON RAPID TORSO COIL, MODEL MR-RBC-150N	Jun 18, 2008	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K081118	NORAS MR-BI320-PA 1.5T	May 02, 2008	Substantially Equivalent	Noras Mri Products GmbH
K080820	TEM 3002G- HN DUAL TUNE HEAD COIL	Apr 02, 2008	Substantially Equivalent	Mr Instruments, Inc.
K080120	HFO SHOULDER COIL	Mar 10, 2008	Substantially Equivalent	Philips Medical Systems MR Finland
K080062	OASIS RAPID BREAST COIL, MODEL MR-IBC-120 AND OASIS RAPID NV COIL, MODEL MR-NVC-120	Feb 11, 2008	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K073310	OASIS CTL COIL, OD FLEXIBLE BODY COIL (L AND XL), AND RAPID FOOT COIL	Jan 18, 2008	Substantially Equivalent	Hitachi Medical Corp.
K073131	MICROMRI WRIST COIL	Jan 18, 2008	Substantially Equivalent	Micromri, Inc.
K073236	NEOCOIL 3.0T 32-CHANNEL TORSO ARRAY COIL FOR GE	Nov 30, 2007	Substantially Equivalent	Neocoil
K073181	NEOCOIL 1.5T 16 CHANNEL CARDIAC-ABDOMINAL-PELVIC ARRAY COIL	Nov 21, 2007	Substantially Equivalent	Neocoil, LLC
K072874	LBS-127-16 BREAST ARRAY COIL	Nov 16, 2007	Substantially Equivalent	Invivo
K072873	LBS-63-16 BREAST ARRAY COIL	Nov 16, 2007	Substantially Equivalent	Invivo
K072935	SPEEDER 1.5T WRIST ARRAY COIL	Oct 31, 2007	Substantially Equivalent	Quality Electrodynamics
K072909	1.5T 32-CHANNEL HEAD COIL AND 3T 32-CHANNEL HEAD COIL	Oct 31, 2007	Substantially Equivalent	Siemens AG Medical Solutions
K072931	MC 3003G-32R HEAD COIL	Oct 30, 2007	Substantially Equivalent	Mr Instruments, Inc.
K071966	1.5T MRGFUS PELVIC COIL	Sep 05, 2007	Substantially Equivalent	Insightec-Txsonics, Inc.
K071847	MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL CG-KFC18-H150-AP - KNEE/FOOT/ANKLE COIL	Jul 23, 2007	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.
K071882	MODEL CG-WHC18-H150-AP - WRIST HAND COIL 1.5T 4 CH,	Jul 18, 2007	Substantially Equivalent	Shanghai Chenguang Medical Technologies Co, Ltd.
K071534	CONFIRMA BREAST MRI INTERVENTIONAL COMPONENTS	Jul 09, 2007	Substantially Equivalent	Confirma, Inc.
K071611	NEOCOIL 3.0T 8-CHANNEL SHOULDER ARRAY COIL	Jun 28, 2007	Substantially Equivalent	Neocoil
K071179	NORAS OR HEAD HOLDER	Jun 13, 2007	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K071311	NEOCOIL 1.5T 8-CHANNEL SHOULDER ARRAY COIL	May 22, 2007	Substantially Equivalent	Neocoil
K070778	NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL	Apr 11, 2007	Substantially Equivalent	Neocoil
K070629	FLEX AND LOOP COIL SET 1.5 T	Mar 26, 2007	Substantially Equivalent	Siemens Medical Solutions
K063513	ECHELON MR-RCC-150 CARDIAC COIL	Dec 12, 2006	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K063342	MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS	Nov 30, 2006	Substantially Equivalent	Medrad, Inc.
K063373	FLEX LOOP COIL SET 3T	Nov 17, 2006	Substantially Equivalent	Siemens AG
K062767	CTL-63 AND CTL-128 SPINE ARRAY COILS	Oct 13, 2006	Substantially Equivalent	Invivo Corporation
K062556	ECHELON SHOULDER COIL	Oct 05, 2006	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K061950	HHF1 ECHELON MULTI-PURPOSE COIL	Aug 18, 2006	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K061952	CARDIOVASCULAR ARRAY COILS, MODELS CAC-63-16, CAC-63-32, CAC-123-32 AND CAC-127-16	Jul 28, 2006	Substantially Equivalent	Invivo
K061715	MRGFUS GENERAL PURPOSE AND BREAST COIL	Jul 28, 2006	Substantially Equivalent	Insightec Txsonics, Inc.
K061281	INSIGHT HEAD COIL	Jun 19, 2006	Substantially Equivalent	Insight Neuroimaging Systems, LLC
K061170	3.0T PEDIATRIC HEAD AND SPINE ARRAY, MODEL 808GE3000	May 25, 2006	Substantially Equivalent	Resonance Innovations, LLC
K060758	OR HEAD COIL 1.5 T	May 05, 2006	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K060873	VANGUARD MRI AUXILIARY PATIENT TABLE WITH 4 AND 8 CHANNEL COIL ARRAY FOR GE SIGNA SYSTEMS	Apr 14, 2006	Substantially Equivalent	Sentinelle Medical, Inc.
K060689	1.5T PEDIATRIC HEAD AND SPINE ARRAY MODEL	Mar 31, 2006	Substantially Equivalent	Resonance Innovations, LLC
K060547	ACCESS BREAST COIL 4/SMS	Mar 29, 2006	Substantially Equivalent	Confirma, Inc.
K060401	MEDRAD 3.0T ECOIL IMAGING SYSTEM	Mar 15, 2006	Substantially Equivalent	Medrad, Inc.
K053042	MEDRAD 1.5T PELVIC IMAGING SYSTEM INTERFACE DEVICE	Nov 17, 2005	Substantially Equivalent	Medrad, Inc.
K053017	MODELS HRS-63-8 AND HRS-127-8 SHOULDER ARRAY COILS	Nov 16, 2005	Substantially Equivalent	Invivo Corporation
K052916	USA INSTRUMENTS 3.0T BRAIN/SPINE ARRAY	Nov 09, 2005	Substantially Equivalent	Usa Instruments, Inc.
K052704	MODEL BBD BREAST IMMOBILIZATION AND BIOPSY DEVICE	Nov 03, 2005	Substantially Equivalent	Invivo Corp.
K052827	MODIFICATION TO MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL FOR SIEMENS	Nov 01, 2005	Substantially Equivalent	Medrad, Inc.
K052497	NEUROVASCULAR ARRAY COIL, MODEL NVA-127-16-A	Oct 12, 2005	Substantially Equivalent	Invivo Corp.
K052621	1.5T 16 CHANNEL BRAIN-SPINE ARRAY COIL	Oct 07, 2005	Substantially Equivalent	Usa Instruments, Inc.
K052584	1.5T 12 CHANNEL BODY ARRAY	Oct 07, 2005	Substantially Equivalent	Usa Instruments, Inc.
K052585	3T HD BREAST ARRAY	Oct 04, 2005	Substantially Equivalent	Usa Instruments, Inc.
K052045	ACCESS BREAST COIL	Aug 24, 2005	Substantially Equivalent	Confirma, Inc.
K052200	TEM 3000 HEAD COIL	Aug 19, 2005	Substantially Equivalent	Mr Instruments, Inc.
K052077	G-SCAN CERVICAL SPINE COIL	Aug 16, 2005	Substantially Equivalent	Esaote, S.p.A.
K051618	SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64	Aug 02, 2005	Substantially Equivalent	Midwest Rf, LLC
K051763	QD KNEE/FOOT COIL, MODEL MJQJ-147A	Jul 14, 2005	Substantially Equivalent	Toshiba America Medical Systems, In.C
K051512	CAC-127-8 CARDOAC ARRAY COIL	Jun 28, 2005	Substantially Equivalent	Invivo Corp.
K050728	OPEN BREAST COIL (OBC) WITH BIOPSY PLATES	Jun 28, 2005	Substantially Equivalent	Usa Instruments, Inc.
K051349	3.0T PROSTATE IMAGING SYSTEM	Jun 23, 2005	Substantially Equivalent	Medrad, Inc.
K050622	HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL	Apr 08, 2005	Substantially Equivalent	Mri Devices Corporation
K050621	NVA-127-8-A NEUROVASCULAR ARRAY COIL	Apr 07, 2005	Substantially Equivalent	Mri Devices Corporation
K050514	MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS	Mar 25, 2005	Substantially Equivalent	Mri Devices Corporation
K050476	CORDLESS COIL	Mar 25, 2005	Substantially Equivalent	Siemens Medical Solution, Inc. USA
K050307	AIRIS ELITE RAPID BODY COIL	Feb 28, 2005	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K050299	HRK-123 KNEE ARRAY COIL	Feb 24, 2005	Substantially Equivalent	Mri Devices Corporation
K042718	13C/1H OCCIPITAL HEADCOIL FOR MAGNETOM ALLEGRA	Nov 12, 2004	Substantially Equivalent	Siemens Medi Cal Solutions, Inc.
K042617	31P/1H HEADCOIL FOR MAGNETOM ALLEGRA	Nov 05, 2004	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K042844	GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL	Nov 03, 2004	Substantially Equivalent	Ge Medical Systems, Inc.
K042342	MILLENNIUM III 3T-8-CHANNEL NEUROVASCULAR COIL	Sep 24, 2004	Substantially Equivalent	Usa Instruments, Inc.
K042207	11000 RAPTURE PHASED ARRAY PERIPHERAL VASCULAR COIL	Aug 26, 2004	Substantially Equivalent	Usa Instruments, Inc.
K042186	3.0T 8-CHANNEL CTL SPINE ARRAY	Aug 26, 2004	Substantially Equivalent	Usa Instruments, Inc.
K042103	NVA-63-8-A AND NVA-63-16-A NEUROVASCULAR ARRAY COIL	Aug 16, 2004	Substantially Equivalent	Mri Devices Corporation
K042009	MARK III PHASED ARRAY SHOULDER COIL	Aug 11, 2004	Substantially Equivalent	Usa Instruments, Inc.
K041921	GE SIGNA PROFILE 6 INCH GP COIL	Jul 26, 2004	Substantially Equivalent	Ge Medical Systems, LLC
K041481	MODEL BBC-127 BIOPSY BREAST COIL	Jul 19, 2004	Substantially Equivalent	Mri Devices Corp.
K041487	QD HEAD SPEEDER WITH SPEEDER NV ATTACHMENT	Jun 17, 2004	Substantially Equivalent	Usa Instruments, Inc.
K041185	TORSO ARRAY COIL, MODEL 558GE-64	May 14, 2004	Substantially Equivalent	Igc-Medical Advances, Inc.
K041145	MODIFICATION TO E-SCAN XQ MRI SYSTEM	May 14, 2004	Substantially Equivalent	Esaote, S.p.A.
K040937	TEM 3000 HEAD COIL	Apr 23, 2004	Substantially Equivalent	Mr Instruments, Inc.
K040122	MAYO CLINIC BC-10 3.0T	Apr 14, 2004	Substantially Equivalent	Mayo Clinic
K040640	MODEL 475 - 8 CHANNEL T/R PHASED ARRAY LOWER EXTREMITY COIL	Mar 22, 2004	Substantially Equivalent	Igc-Medical Advances, Inc.
K040349	MODIFICATION TO HRW-127 WRIST ARRAY COIL	Mar 09, 2004	Substantially Equivalent	Mri Devices Corp.
K040348	MODIFICATION TO HNC-127-INT NEUROVASCULAR ARRAY COIL	Mar 09, 2004	Substantially Equivalent	Mri Devices Corp.
K040288	QSC-127-INT SHOULDER ARRAY COIL SET	Mar 05, 2004	Substantially Equivalent	Mri Devices Corp.
K033662	SYNERGY SPINE ARRAY COIL	Feb 02, 2004	Substantially Equivalent	Philips Medical Systems, Inc.
K033490	SPIRIT 5000 CARDIAC COIL	Jan 09, 2004	Substantially Equivalent	Usa Instruments, Inc.
K033753	PELVIC ARRAY COIL	Dec 17, 2003	Substantially Equivalent	Usa Instruments, Inc.
K033235	GEMINI III HYBRID TX/RX 4 CHANNEL HEAD COIL	Dec 17, 2003	Substantially Equivalent	Usa Instruments, Inc.
K033292	AIRIS-ELITE RAPID BODY COIL, MODEL 554HI-12	Nov 26, 2003	Substantially Equivalent	Igc-Medical Advances, Inc.
K033567	MODELS HRK-63-8 PMS AND HRK-127-8 KNEE ARRAY COILS	Nov 25, 2003	Substantially Equivalent	Mri Devices Corp.
K033353	MODIFICATION TO LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES	Nov 14, 2003	Substantially Equivalent	Usa Instruments, Inc.
K032576	BIOPSY BREAST COIL, MODEL BBC	Oct 23, 2003	Substantially Equivalent	Mri Devices Corp.
K033152	HAC-12 AND HAC-30 HEAD ARRAY COIL	Oct 10, 2003	Substantially Equivalent	Mri Devices Corp.
K033151	KFA-12 KNEE, FOOT, AND ANKLE ARRAY COIL	Oct 10, 2003	Substantially Equivalent	Mri Devices Corp.
K032633	HRK-63-8 KNEE ARRAY COIL	Sep 25, 2003	Substantially Equivalent	Mri Devices Corp.
K032618	3.0T 8 CHANNEL NEUROVASCULAR (NV) ARRAY COIL	Sep 12, 2003	Substantially Equivalent	Usa Instruments, Inc.
K032538	3.0T 8-CHANNEL CERVICAL-THORACIC-LUMBAR (CTL) ARRAY COIL	Sep 12, 2003	Substantially Equivalent	Usa Instruments, Inc.
K032474	3.0T 4-CHANNEL CERVICO-THORACIC-LUMBAR (CTL) ARRAY COIL	Aug 25, 2003	Substantially Equivalent	Usa Instruments, Inc.
K032415	MILLENNIUM III 4 CHANNEL NEUROVASCULAR COIL	Aug 25, 2003	Substantially Equivalent	Usa Instruments, Inc.
K032429	QSC-127 SHOULDER ARRAY COIL SET	Aug 21, 2003	Substantially Equivalent	Mri Devices Corp.
K032090	NEUROVASCULAR ARRAY COIL, MODEL NVA-127-8	Aug 21, 2003	Substantially Equivalent	Mri Devices Corp.
K032045	8 CHANNEL CARDIAC PHASED ARRAY COIL	Jul 30, 2003	Substantially Equivalent	GE Medical Systems
K031536	BRAIN COIL, MODEL 9900GE-64	Jul 18, 2003	Substantially Equivalent	Clinical MR Solutions, LLC
K031365	PRIMA III TOTALSENSE TORSO COIL	Jul 18, 2003	Substantially Equivalent	Usa Instruments, Inc.
K031119	MAYO CLINIC BC-10 1.5T	Jul 15, 2003	Substantially Equivalent	Mayo Medical Ventures
K031366	PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL	Jul 11, 2003	Substantially Equivalent	Usa Instruments, Inc.
K031095	SENSE BODY COIL	Jun 20, 2003	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K031172	SPIRIT III TOTALSENSE CARDIAC COIL	May 29, 2003	Substantially Equivalent	Usa Instruments, Inc.
K031143	ALPHA 5000 WRIST COIL	May 29, 2003	Substantially Equivalent	Usa Instruments, Inc.
K031139	PREMIER III PHASED ARRAY CTL SPINE COIL	May 29, 2003	Substantially Equivalent	Usa Instruments, Inc.
K031209	GE 1.5T 8 CHANNEL TORSO COIL	May 23, 2003	Substantially Equivalent	Ge Medical Systems, Inc.
K031089	GORE-FLEX MP8 MULTIPURPOSE TORSO ARRAY	May 08, 2003	Substantially Equivalent	W. L. Gore & Associates, Inc.
K031056	MODIFICATION TO PREMIER III PHASED ARRAY CTL SPINE COIL	May 08, 2003	Substantially Equivalent	Usa Instruments, Inc.
K030371	PRIMA III TOTALSENSE TORSO COIL	May 05, 2003	Substantially Equivalent	Usa Instruments, Inc.
K030540	HTS ARRAY COIL	Apr 16, 2003	Substantially Equivalent	Jockey Club Mri Engineering Center
K030953	GE 3.0T GENERAL PURPOSE FLEX COIL	Apr 10, 2003	Substantially Equivalent	Ge Medical Systems, Inc.
K030317	MODEL 1300GE-64: PEDIATRIC POSITIONER	Mar 25, 2003	Substantially Equivalent	Midwest Rf, LLC
K030495	3.0T TORSO PHASED ARRAY COIL	Mar 05, 2003	Substantially Equivalent	Ge Medical Systems, Inc.
K030042	PREMIER III PHASED ARRAY CTL SPINE COIL	Feb 24, 2003	Substantially Equivalent	Usa Instruments, Inc.
K023982	LEO III TX/RX QUADRATURE KNEE COIL; ALPHA III TX/RX QUADRATURE WRIST COIL	Feb 21, 2003	Substantially Equivalent	Usa Instruments, Inc.
K023929	MAGNETIC RESONANCE DIAGNOSTIC DEVICE	Feb 21, 2003	Substantially Equivalent	Advanced Imaging Research, Inc.
K023848	MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:	Feb 14, 2003	Substantially Equivalent	Igc-Medical Advances, Inc.
K024187	SPIRIT III TOTALSENSE CARDIAC COIL	Feb 04, 2003	Substantially Equivalent	Usa Instruments, Inc.
K022863	HTS COIL	Feb 04, 2003	Substantially Equivalent	Jockey Club Mri Engineering Center
K023650	INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PLEVIS COIL	Jan 24, 2003	Substantially Equivalent	Usa Instruments, Inc.
K024354	PHSL-63-SYM AND PHS-63-SYM PEDIATRIC HEAD AND SPINE ARRAY COILS	Jan 09, 2003	Substantially Equivalent	Mri Devices Corp.
K024352	HRH-127-8 HEAD ARRAY COIL FOR GE SIGNA 3T EXCITE MRI SYSTEM	Jan 09, 2003	Substantially Equivalent	Mri Devices Corp.
K024209	QWH-250-PAN WRIST ARRAY COIL	Jan 09, 2003	Substantially Equivalent	Mri Devices Corp.
K024208	OBC-250-PAN BREAST ARRAY COIL	Jan 07, 2003	Substantially Equivalent	Mri Devices Corp.
K023247	CHAMPION 5000 PERIPHERAL VASCULAR COIL	Dec 23, 2002	Substantially Equivalent	Usa Instruments, Inc.
K023084	MODEL 472GE-128: QUADRATURE LOWER EXTREMITY COIL	Dec 16, 2002	Substantially Equivalent	Medical Advances, Inc.
K023571	6 CHANNEL BODY COIL	Nov 20, 2002	Substantially Equivalent	Siemens Medical Systems, Inc.
K023679	GORE 3.0T TORSO ARRAY	Nov 18, 2002	Substantially Equivalent	W. L. Gore & Associates, Inc.
K023596	MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL	Nov 08, 2002	Substantially Equivalent	Medrad, Inc.
K023442	EXTRA LARGE BODY COIL	Nov 05, 2002	Substantially Equivalent	GE Medical Systems
K022007	LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES	Nov 04, 2002	Substantially Equivalent	Usa Instruments, Inc.
K022582	EXCALIBUR 9000 TOTALSENSE QUAD HEAD ARRAY COIL	Oct 22, 2002	Substantially Equivalent	Usa Instruments, Inc.
K023164	BBC-63-GE BREAST ARRAY COIL	Oct 11, 2002	Substantially Equivalent	Mri Devices Corp.
K022910	QSC-63-INT SHOULDER ARRAY COIL SET	Oct 03, 2002	Substantially Equivalent	Mri Devices Corp.
K022883	HRK-63 KNEE ARRAY COIL	Sep 27, 2002	Substantially Equivalent	Mri Devices Corp.
K022720	CTL-63-8 CERVICAL/THORACIC/LUMBAR SPINE ARRAY COIL	Sep 06, 2002	Substantially Equivalent	Mri Devices Corp.
K022669	8 CHANNEL CARDIAC PHASED ARRAY COIL	Sep 06, 2002	Substantially Equivalent	GE Medical Systems
K022588	HRW-63-INT WRIST ARRAY COIL	Sep 04, 2002	Substantially Equivalent	Mri Devices Corp.
K022488	MODEL OBC-63 BREAST ARRAY COIL	Aug 23, 2002	Substantially Equivalent	Mri Devices Corp.
K022487	MODEL EXS-63-INT SMALL EXTREMITY ARRAY COIL	Aug 23, 2002	Substantially Equivalent	Mri Devices Corp.
K021751	ALTAIRE MAGNETIC RESONANCE IMAGING SYSTEM	Aug 15, 2002	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K022395	1.5T SCANMED PV ARRAY	Aug 13, 2002	Substantially Equivalent	Medic, Inc.
K022372	HRH-127-8 HEAD ARRAY COIL	Aug 13, 2002	Substantially Equivalent	Mri Devices Corp.
K021631	ISA-21 INTERVENTIONAL SPINE ARRAY COIL	Aug 13, 2002	Substantially Equivalent	Mri Devices Corp.
K021330	MAGNETOM TRIO QUADRATURE TX/RX HEAD COIL	Jul 25, 2002	Substantially Equivalent	Usa Instruments, Inc.
K021141	MILLENNIUM 5000 MEUROVASCULAR COIL	Jun 27, 2002	Substantially Equivalent	Usa Instruments, Inc.
K021433	MODEL 415PH-64/42: PHASED ARRAY SHOULDER COIL	Jun 13, 2002	Substantially Equivalent	Medical Advances, Inc.
K021575	OBC-127 BREAST ARRAY COIL	Jun 12, 2002	Substantially Equivalent	Mri Devices Corp.
K021570	HNC-127-TRIO NEUROVASCULAR ARRAY COIL	Jun 12, 2002	Substantially Equivalent	Mri Devices Corp.
K020850	GPF-29 GENERAL PURPOSE COIL SET	Jun 06, 2002	Substantially Equivalent	Mri Devices Corp.
K021262	MAGNETOM SYMPHONY QUADRATURE TX/RX HEAD COIL	May 21, 2002	Substantially Equivalent	Usa Instruments, Inc.
K020993	ILLUMINATOR AUTOMATIC TUNE VOX AND INTERFACE CABLE (ATIB)	May 21, 2002	Substantially Equivalent	Magna-Lab, Inc.
K020790	INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL MICROCOIL, AND INTERCEPT VASCULAR INTERNAL MR COIL	May 21, 2002	Substantially Equivalent	Surgi-Vision, Inc.
K020601	FLEXICOIL - MALLEABLE RECEIVE-ONLY SURFACE COIL	Apr 24, 2002	Substantially Equivalent	Odin Medical Technologies , Ltd.
K020495	INTERCEPT ESOPHAGEAL INTERNAL MR COIL, INTERCEPT URETHRAL INTERNAL MR COIL, AND INTERCEPT VASCULAR INTERNAL MR COIL	Apr 23, 2002	Substantially Equivalent	Surgi-Vision, Inc.
K020606	NVA-63-8 NEUROVASCULAR ARRAY COIL	Mar 13, 2002	Substantially Equivalent	Mri Devices Corp.
K013854	MARK 5000 QUADRATURE SHOULDER COIL	Feb 06, 2002	Substantially Equivalent	Usa Instruments, Inc.
K014086	CTL BODY / SPINE ARRAY COIL	Feb 05, 2002	Substantially Equivalent	Usa Instruments, Inc.
K020036	EXS-63 SMALL EXTREMITY ARRAY COIL	Feb 01, 2002	Substantially Equivalent	Mri Devices Corp.
K013985	MACHNET BILATERAL OPEN BREAST COIL. CATALOG # MICS-GSXX	Feb 01, 2002	Substantially Equivalent	Machnet BV
K013595	PREMIER III PHASED ARRAY CTL SPINE COIL	Jan 22, 2002	Substantially Equivalent	Usa Instruments, Inc.
K013594	BODY ARRAY COIL	Jan 22, 2002	Substantially Equivalent	Usa Instruments, Inc.
K013894	TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T	Jan 18, 2002	Substantially Equivalent	Philips Medical Systems North America, Inc.
K013592	EXTREMITY COIL	Jan 08, 2002	Substantially Equivalent	Usa Instruments, Inc.
K013514	PHSL-63 PEDIATRIC HEAD AND SPINE ARRAY COIL	Jan 02, 2002	Substantially Equivalent	Mri Devices Corp.
K013541	SHOULDER COIL	Dec 14, 2001	Substantially Equivalent	Usa Instruments, Inc.
K013528	CRYSTAL 5000 PHASES ARRAY TMJ COIL	Dec 13, 2001	Substantially Equivalent	Usa Instruments, Inc.
K011683	NURVO 9000 ENDOCAVITARY COILS	Dec 10, 2001	Substantially Equivalent	Usa Instruments, Inc.
K013810	CARDIOVASCULAR ARRAY	Nov 27, 2001	Substantially Equivalent	W. L. Gore & Associates, Inc.
K013602	HNC-63-INT NEUROVASCULAR ARRAY COIL	Nov 20, 2001	Substantially Equivalent	Mri Devices Corp.
K013508	HRH-127-ALLEGRA HEAD ARRAY COIL	Nov 20, 2001	Substantially Equivalent	Mri Devices Corp.
K012491	MACHNET CAROTIDS COIL ARRAY ASSEMBLY	Oct 24, 2001	Substantially Equivalent	Machnet BV
K013322	HAC-420 HEAD ARRAY COIL	Oct 16, 2001	Substantially Equivalent	Mri Devices Corp.
K013159	HRH-63-8 HEAD ARRAY COIL	Oct 16, 2001	Substantially Equivalent	Mri Devices Corp.
K013099	MODIFICATION TO: QWH-420 WRIST ARRAY COIL	Sep 25, 2001	Substantially Equivalent	Mri Devices Corp.
K011781	INTERCEPT-URETHRAL MICROCOIL	Aug 31, 2001	Substantially Equivalent	Surgi-Vision, Inc.
K012728	E-SCAN MRI SYSTEM	Aug 29, 2001	Substantially Equivalent	Biosound Esaote, Inc.
K012353	HNC-127 NEUROVASCULAR ARRAY COIL	Aug 14, 2001	Substantially Equivalent	Mri Devices Corp.
K011608	MODEL 235GE-64; MULTI PURPOSE FLEX ARRAY COIL	Aug 14, 2001	Substantially Equivalent	Medical Advances, Inc.
K010802	CARDIAC VIEW, MODEL 2001	Jun 08, 2001	Substantially Equivalent	Magna Lab, Inc.
K010946	MARK 9000 PHASED ARRAY SHOULDER COIL	May 30, 2001	Substantially Equivalent	Usa Instruments, Inc.
K003505	KFA-127 KNEE, FOOT AND ANKLE ARRAY	May 25, 2001	Substantially Equivalent	Mri Devices Corp.
K010513	CARDIAC VIEW, MODEL 2001	May 21, 2001	Substantially Equivalent	Magna-Lab, Inc.
K010730	MODIFICATION TO FLOW 7000 PERIPHERAL VASCULAR COIL	May 16, 2001	Substantially Equivalent	Usa Instruments, Inc.
K010074	MODEL 455GE PHASED ARRAY WRIST COIL	Apr 03, 2001	Substantially Equivalent	Medical Advances, Inc.
K003613	3.0.T SIGNA VH/I (T/R) BODY IMAGING COIL	Apr 03, 2001	Substantially Equivalent	GE Medical Systems
K003946	SIGNA SP 0.5T ROTATING HORIZONTAL BODY COIL	Feb 27, 2001	Substantially Equivalent	GE Medical Systems
K010140	HRH-127 HEAD ARRAY COIL	Feb 22, 2001	Substantially Equivalent	Mri Devices Corp.
K003655	PHS-63 PEDIATRIC HEAD AND SPINE ARRAY COIL	Feb 02, 2001	Substantially Equivalent	Mri Devices Corp.
K003436	SURGI-VISION GUIDEWIRE COIL	Feb 02, 2001	Substantially Equivalent	Surgi-Vision, Inc.
K001097	ACTIVE ARRAY CATHETER, MODEL CS-2000	Jan 18, 2001	Substantially Equivalent	Image-Guided Neurologics, Inc.
K003386	SPECIAL PROCEDURES HEAD COIL; MODEL # 1100GE-64	Dec 28, 2000	Substantially Equivalent	Midwest Rf, LLC
K003097	BRAIN COIL, MODEL 9800GE-64	Dec 28, 2000	Substantially Equivalent	Midwest Rf, LLC
K003685	MODEL 342GE-64 HIGH RESOLUTION BRAIN COIL	Dec 22, 2000	Substantially Equivalent	Medical Advances, Inc.
K003366	MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL	Dec 22, 2000	Substantially Equivalent	Igc-Medical Advances, Inc.
K003144	MODEL 205GE-64: PATHWAY MRI CAROTID ARRAY COIL	Dec 13, 2000	Substantially Equivalent	Medical Advances, Inc.
K002916	SURGI-VISION PROSTATE COIL	Nov 28, 2000	Substantially Equivalent	Surgi-Vision, Inc.
K002860	MODEL 6900GE-64: C-SPINE ARRAY	Nov 22, 2000	Substantially Equivalent	Midwest Rf, LLC
K002864	MODEL 6600GE-64: TRAMA NECK ARRAY	Nov 21, 2000	Substantially Equivalent	Midwest Rf, LLC
K002774	HRH-63 HEAD ARRAY COIL	Nov 16, 2000	Substantially Equivalent	Mri Devices Corp.
K003340	OBC-149 BREAST ARRAY COIL	Nov 08, 2000	Substantially Equivalent	Mri Devices Corp.
K003331	QWH-149 WRIST ARRAY COIL	Nov 08, 2000	Substantially Equivalent	Mri Devices Corp.
K002522	OPART, MODEL MRT-600	Oct 25, 2000	Substantially Equivalent	Toshiba America Mri, Inc.
K002483	POWER 5000 GENERAL PURPOSE COIL	Oct 25, 2000	Substantially Equivalent	Usa Instruments, Inc.
K002482	VISION 9000 PHASED ARRAY TORSO COIL	Oct 17, 2000	Substantially Equivalent	Usa Instruments, Inc.
K002345	SURGI-VISION URETHRAL COIL	Oct 11, 2000	Substantially Equivalent	Surgi-Vision, Inc.
K002602	OBC-63 MEBREAST ARRAY COIL	Sep 05, 2000	Substantially Equivalent	Mri Devices Corp.
K002539	OBC-096 BREAST ARRAY COIL	Aug 30, 2000	Substantially Equivalent	Mri Devices Corp.
K001946	NEUROVASCULAR ARRAY COIL	Aug 30, 2000	Substantially Equivalent	Ge Medical Systems, Inc.
K001944	HAC-300 HEAD ARRAY COIL	Aug 14, 2000	Substantially Equivalent	Mri Devices Corp.
K001870	MILLENNIUM 9000 PHASED ARRAY NEUROVASCULAR COIL	Aug 14, 2000	Substantially Equivalent	Usa Instruments, Inc.
K001582	LIBERTY 9000 BREAST COIL WITH DISPOSABLE BIOPSY PLATE	Jul 17, 2000	Substantially Equivalent	Usa Instruments, Inc.
K001312	MODEL 473SI-64E QUADRATURE LOWER EXTREMITY COIL	Jun 20, 2000	Substantially Equivalent	Igc-Medical Advances, Inc.
K001303	BREAST IMMOBILIZATION DEVICE MR-BY 160	Jun 20, 2000	Substantially Equivalent	Mri Devices Corp.
K001713	HRW-42 WRIST ARRAY COIL FOR 1.0 TESLA	Jun 14, 2000	Substantially Equivalent	Mri Devices Corp.
K001331	SYNERGY HEAD/NECK COIL	Jun 09, 2000	Substantially Equivalent	Philips Medical Systems North America, Inc.
K001210	HI-RES 9000 PHASED ARRAY CAROTID COIL	Jun 09, 2000	Substantially Equivalent	Usa Instruments, Inc.
K001209	INSIGHT PLUS 9000 PHASED ARRAY TORSO AND PELVIS COIL	Jun 01, 2000	Substantially Equivalent	Usa Instruments, Inc.
K000993	LIBERTY 9000 BREAST COIL	May 26, 2000	Substantially Equivalent	Usa Instruments, Inc.
K000549	OPART, MODEL MRT-600	Apr 20, 2000	Substantially Equivalent	Toshiba America Mri, Inc.
K000437	INTERVENTIONAL BODY COIL	Apr 14, 2000	Substantially Equivalent	Usa Instruments, Inc.
K000345	MULTI PURPOSE FLEX ARRAY COIL : MODEL 235 SERIES	Apr 11, 2000	Substantially Equivalent	Medical Advances, Inc.
K000935	KFA-63 KNEE AND FOOT ARRAY	Apr 07, 2000	Substantially Equivalent	Mri Devices Corp.
K994436	SURGI-VISION ESOPHAGEAL STYLET COIL	Mar 14, 2000	Substantially Equivalent	Surgi-Vision, Inc.
K000589	MODEL 445SI-64E QUADRATURE WRIST COIL	Mar 14, 2000	Substantially Equivalent	Igc-Medical Advances, Inc.
K994378	AIRIS II	Mar 07, 2000	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K000002	MAGNA 5000 PHASED ARRAY CTL SPINE COIL	Feb 23, 2000	Substantially Equivalent	Usa Instruments, Inc.
K994345	MAGNA 5000 PHASED ARRAY CTL SPINE COIL	Feb 14, 2000	Substantially Equivalent	Usa Instruments, Inc.
K994315	CP PERIPHERAL ANGIO ARRAY COIL/ MAGNETOM SYMPHONY SYSTEM	Feb 04, 2000	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K993898	KAC-63 KNEE ARRAY COIL	Feb 04, 2000	Substantially Equivalent	Mri Devices Corp.
K994042	SHARP 9000 PHASED ARRAY BRAIN COIL	Jan 31, 2000	Substantially Equivalent	Usa Instruments, Inc.
K994040	PHASED ARRAY KNEE AND FOOT COIL	Jan 18, 2000	Substantially Equivalent	Usa Instruments, Inc.
K993819	QWH-300 WRIST ARRAY COIL	Dec 03, 1999	Substantially Equivalent	Mri Devices Corp.
K993776	OBC-300 BREAST ARRAY COIL	Dec 03, 1999	Substantially Equivalent	Mri Devices Corp.
K993780	QSC-300 SHOULDER ARRAY COILS	Nov 26, 1999	Substantially Equivalent	Mri Devices Corp.
K993719	KAC-300 KNEE ARRAY COIL	Nov 26, 1999	Substantially Equivalent	Mri Devices Corp.
K993477	HRW WRIST ARRAY COIL	Nov 01, 1999	Substantially Equivalent	Mri Devices Corp.
K993279	QSC-085 SHOULDER ARRAY COIL	Oct 15, 1999	Substantially Equivalent	Mri Devices Corp.
K993235	QWH-085 WRIST ARRAY COIL	Oct 15, 1999	Substantially Equivalent	Mri Devices Corp.
K993233	OBC-085 BREAST ARRAY COIL	Oct 15, 1999	Substantially Equivalent	Mri Devices Corp.
K992650	AIRIS, AIRIS II	Oct 08, 1999	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K992193	ENDO-ESOPHAGEAL MR COIL	Sep 03, 1999	Substantially Equivalent	Surgi-Vision, Inc.
K991765	SYNERGY SHOULDER COIL	Aug 02, 1999	Substantially Equivalent	Philips Medical Systems North America, Inc.
K991740	OPART, MODEL MRT-600	Aug 02, 1999	Substantially Equivalent	Toshiba America Mri, Inc.
K991724	QUADRATURE LOWER EXTREMITY COIL, MODEL 473PH-64	Aug 02, 1999	Substantially Equivalent	Medical Advances, Inc.
K991434	QUADRATURE WRIST COIL, MODEL 445PH-64	Jul 06, 1999	Substantially Equivalent	Medical Advances, Inc.
K991113	`INEAR WRIST COIL, MODEL 440GE-09	Jun 10, 1999	Substantially Equivalent	Medical Advances, Inc.
K991115	LINEAR SHOULDER COIL, MODEL 414GE-09	Jun 08, 1999	Substantially Equivalent	Medical Advances, Inc.
K991057	EXTRA LARGE BODY COIL FOR OPART (MRT-600)	May 20, 1999	Substantially Equivalent	Toshiba America Mri, Inc.
K990007	OPART, MODEL MRT-600	Apr 01, 1999	Substantially Equivalent	Toshiba America Mri, Inc.
K983139	SIGNA 1.5T PHOSPHORUS (P) TRANSMIT/RECEIVE FLEX COIL	Feb 19, 1999	Substantially Equivalent	GE Medical Systems
K984588	PHASED ARRAY FLEXIBLE CARDIAC COIL	Feb 08, 1999	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K984257	MEDRAD PHASED ARRAY NEUROVASCULAR COIL	Jan 25, 1999	Substantially Equivalent	Medrad, Inc.
K984159	MEDRAD QUADRATURE CTL ARRAY COIL	Jan 12, 1999	Substantially Equivalent	Medrad, Inc.
K984278	MAGNETIC RESONANCE DIAGNOSTIC DEVICE, AIRIS II	Dec 11, 1998	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K984272	MAGNETIC RESONANCE DIAGNOSTIC DEVICE, MODEL MRP-5000	Dec 11, 1998	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K982978	MODEL 340GE-21C QUADRATURE BRAIN COIL	Nov 23, 1998	Substantially Equivalent	Medical Advances, Inc.
K983143	MARK 5000 PHASED ARRAY SHOULDER COIL	Nov 16, 1998	Substantially Equivalent	Usa Instruments, Inc.
K982972	SIGNA PROFILE SMALL HEAD COIL	Nov 16, 1998	Substantially Equivalent	GE Medical Systems
K982921	MEDRAD 0.5T, 1.0T & 1.5T BREAST COIL, MODELS M21BRC, M42BRA, M64BRA	Nov 03, 1998	Substantially Equivalent	Medrad, Inc.
K982919	MEDRAD QUAD T/L COIL (1.5T, 1.0T & 0.5T) MODELS M64TLC, M42TLC, M21TLC	Nov 02, 1998	Substantially Equivalent	Medrad, Inc.
K982916	MEDRAD 1.5T, 1.0T & 0.5T SHOULDER COIL, MODELS M64SHC, M42SHC, M21SHC	Oct 29, 1998	Substantially Equivalent	Medrad, Inc.
K982772	SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL	Oct 15, 1998	Substantially Equivalent	Ge Medical Systems, Inc.
K983222	PHASED ARRAY CERVICAL SPINE COIL, MODEL #125GE-64	Oct 08, 1998	Substantially Equivalent	Medical Advances, Inc.
K983109	MODEL 545G-64 PAHASED ARRAY MUSCULOSKELETAL FLEX COIL PACKAGE MODEL 543GE-64: PHASED ARRAY UPPER EXTRENITY FLEX COIL ANY	Oct 06, 1998	Substantially Equivalent	Medical Advances, Inc.
K982496	QUADRATURE LOWER EXTREMITY COIL, MODEL # 473SI-42D	Sep 18, 1998	Substantially Equivalent	Medical Advances, Inc.
K982339	FLOW 7000 PERIPHERAL VASCULAR COIL	Sep 04, 1998	Substantially Equivalent	Usa Instruments, Inc.
K981959	OUTLOOK LARGE PHASED ARRAY NECK COIL	Jul 31, 1998	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K981406	CERVIX COIL LATEX SHEATH	Jul 16, 1998	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K981094	MEDRAD NEUROVASCULAR COIL	Jun 18, 1998	Substantially Equivalent	Medrad, Inc.
K980691	AIRIS MAGNETIC RESONANCE DIAGNOSTIC DEVICE	May 11, 1998	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K974438	MEDRAD ATD-T INTERFACE DEVICE	Apr 30, 1998	Substantially Equivalent	Medrad, Inc.
K980157	PREMIER 7000 CTL SPINE COIL	Apr 13, 1998	Substantially Equivalent	Usa Instruments, Inc.
K974308	MEDRAD 1.5T PERIPHERAL VASCULAR ARRAY	Jan 27, 1998	Substantially Equivalent	Medrad, Inc.
K973787	MEDRAD 1.5T EXTREMITY ARRAY	Dec 30, 1997	Substantially Equivalent	Medrad, Inc.
K973630	CP BREAST ARRAY COIL/MAGNETOM HARMONY/SYMPHONY SYSTEM	Dec 05, 1997	Substantially Equivalent	Siemens Medical Solutions USA, Inc.
K972592	2T PRESTIGE(100-6321-0107)/PRIVILEGE(100-6326-0102)/GYREX V-EP(100-6327-0101)	Sep 15, 1997	Substantially Equivalent	Elscint, Inc.
K972296	MAGNETIC RESONANCE DIAGNOSTIC SYSTEM	Sep 15, 1997	Substantially Equivalent	Ge Medical Systems, Inc.
K972205	ALPHA 7000 QUADRATURE WRIST COIL	Sep 05, 1997	Substantially Equivalent	Usa Instruments, Inc.
K972340	INSIGHT 7000 PHASED ARRAY TORSO COIL	Aug 21, 1997	Substantially Equivalent	Usa Instruments, Inc.
K971667	CARDIAC PHASED ARRAY COIL	Jul 23, 1997	Substantially Equivalent	GE Medical Systems
K964969	SIGNA SP CROWN COILS (NUMBERS 1 THROUGH 3)	Jun 26, 1997	Substantially Equivalent	GE Medical Systems
K971246	LEO 7000 QUADRATURE KNEE COIL	Jun 20, 1997	Substantially Equivalent	Usa Instruments, Inc.
K971016	MRP-7000/AIRIS QD C-SPINE COIL (P/N MR-QCSC-42,MR-QCSC-52)	Jun 06, 1997	Substantially Equivalent	Hitachi Medical Systems America, Inc.
K970868	MODEL HNC NEUROVASCULAR ARRAY COIL	Jun 06, 1997	Substantially Equivalent	Mri Devices Corp.
K964820	MAXIM 7000 QUADRATURE EXTREMITY COIL MODEL NUMBER QEC-GEM-15A	Feb 28, 1997	Substantially Equivalent	Us Asia Instruments, Inc.
K964813	MODEL 675GE-64 PERIPHERAL VASCULAR COIL CONSISTING OF MODEL 665GE-64: LOWER EXTREMITY FLEXIBLE ARRAY AND MODEL 538GE-64:	Feb 26, 1997	Substantially Equivalent	Medical Advances, Inc.
K964668	MODELS EXL AND EXS EXTREMITY COIL SET	Feb 18, 1997	Substantially Equivalent	Mri Devices Corp.
K964854	MEDRAD PHASED ARRAY 1.5T SHOULDER IMAGING SURGACE COIL	Feb 11, 1997	Substantially Equivalent	Medrad, Inc.
K964678	PHASED ARRAY NECK COIL	Feb 11, 1997	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K964141	GE STERILE DISPOSABLE EQUIPMENT COIL COVER	Jan 30, 1997	Substantially Equivalent	Contour Fabricators, Inc.
K963356	PHASED ARRAY SHOULDER COIL	Nov 22, 1996	Substantially Equivalent	Philips Medical Systems (Cleveland), Inc.
K961628	MINI FLEX COIL	Sep 05, 1996	Substantially Equivalent	W. L. Gore & Associates, Inc.
K961525	ARRAY OPEN BREAST COIL (MODEL OBC-63 PA)	Sep 05, 1996	Substantially Equivalent	Mri Devices Corp.
K961391	FLEXART QD HEAD/NECK COIL	Jul 09, 1996	Substantially Equivalent	Toshiba America Mri, Inc.
K954952	MEDRAD/HITACHI 1.5T QUAD C-SPINE SURFACE COIL	Mar 13, 1996	Substantially Equivalent	Medrad, Inc.
K955626	MEDRAD/HITACHI BREAST IMAGING SURFACE COIL	Feb 27, 1996	Substantially Equivalent	Medrad, Inc.
K954190	MODEL 580GE-64 QUADRATURE ABDOMINAL FLEX COIL	Nov 20, 1995	Substantially Equivalent	Medical Advances, Inc.
K953595	MAGNETIC RESONANCE DIAGNOSTIC ACCESSORY	Oct 27, 1995	Substantially Equivalent	GE Medical Systems
K952944	MODEL 445SI-64 & 445SI-42A: QUARDRATURE WRIST COIL	Aug 23, 1995	Substantially Equivalent	Medical Advances, Inc.
K950966	MODEL 410SI-64 SHOULDER LOOP PAIR, SMALL & LARGEM NIDEK 410SI-42A SHOULDER LOOP PAIR, SMALL & LARGE	Jul 26, 1995	Substantially Equivalent	Medical Advances, Inc.