Coil, Magnetic Resonance, Specialty
FDA product code MOS · Class II (moderate risk) · 21 CFR 892.1000 · Radiology
490510(k) clearances
0PMA approvals
38recalls
Manufacturers
- Mri Devices Corp. 65
- Usa Instruments, Inc. 63
- Quality Electrodynamics, LLC 33
- Invivo Corporation 21
- GE Medical Systems, LLC 19
- Medical Advances, Inc. 19
- Hitachi Medical Systems America, Inc. 18
- Medrad, Inc. 18
- Neocoil, LLC 18
- Ge Healthcare Coils (Usa Instruments, Inc.) 11
- Shenzhen RF Tech Co., Ltd. 11
- Noras Mri Products GmbH 10
- Siemens Medical Solutions USA, Inc. 8
- Surgi-Vision, Inc. 8
- Midwest Rf, LLC 8
- Shanghai Chenguang Medical Technologies Co, Ltd. 8
- Resonance Innovations, LLC 8
- Rapid Biomedical GmbH 7
- Mr Instruments, Inc. 7
- Igc-Medical Advances, Inc. 7
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil…MOS · Special | Philips Medical Systems Nederland B.V. | 07/30/2026SE |
| K262294 | dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes…MOS · Special | Philips Medical Systems Nederland B.V. | 07/24/2026SE |
| K260947 | 0.55T 12Ch Breast CoilMOS · Special | Neocoil, LLC | 04/23/2026SE |
| K252587 | HD 8Ch Wrist ArrayMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 04/14/2026SE |
| K252876 | GEM Flex Coil 16-L Array, 3.0T Receive Only; GEM Flex Coil 16-M Array, 3.0T Receive…MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 04/01/2026SE |
| K260519 | Smart Fit TorsoCardiac 1.5TMOS · Special | Philips Healthcare (Suzhou) Co., Ltd. | 03/20/2026SE |
| K252179 | GEM Flex Coil 16-L Array, 1.5T Receive Only; GEM Flex Coil 16-M Array, 1.5T Receive…MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 02/10/2026SE |
| K253738 | 3.0T Air 32CH HnaMOS · Abbreviated | Ge Healthcare Coils (Usa Instruments, Inc.) | 01/23/2026SE |
| K254190 | dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0TMOS · Special | Philips Medical Systems Nederland B.V. | 01/14/2026SE |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x)MOS · Special | Inkspace Imaging, Inc. | 10/20/2025SE |
| K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G ConnectorMOS · Abbreviated | Dxtx Medical, Inc. | 07/17/2025SE |
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)MOS · Traditional | Quality Electrodynamics | 02/28/2025SE |
| K243675 | InkSpace Imaging Small Body ArrayMOS · Special | Inkspace Imaging, Inc. | 12/20/2024SE |
| K243316 | XENOVIEW 3.0T Chest CoilMOS · Special | Polarean, Inc. | 11/19/2024SE |
| K243033 | dS Wrist coil 8ch 1.5TMOS · Special | Philips Medical Systems Nederland B.V. | 10/18/2024SE |
| K242879 | dS Knee Coil 8ch 1.5TMOS · Special | Philips Medical Systems Nederland B.V. | 10/18/2024SE |
| K242096 | dS FootAnkle Coil 8ch 1.5TMOS · Special | Philips Medical Systems Nederland B.V. | 08/12/2024SE |
| K241069 | iLoop Interventional Coil 0.55TMOS · Abbreviated | Noras Mri Products GmbH | 06/07/2024SE |
| K233652 | Contour Hand/Wrist (Q7000232)MOS · Traditional | Quality Electrodynamics | 02/16/2024SE |
| K233656 | Contour ShoulderMOS · Traditional | Quality Electrodynamics | 02/15/2024SE |
| K233600 | Smart Fit Knee 3.0TMOS · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 02/05/2024SE |
| K233444 | InkSpace Imaging Small Body ArrayMOS · Special | Inkspace Imaging, Inc. | 01/08/2024SE |
| K233348 | 16 Breast CoilMOS · Special | Philips Medical System Nederlands B.V. | 10/24/2023SE |
| K232762 | dS Breast Coil 7ch 1.5TMOS · Special | Invivo Corporation (Business Trade Name: Philips) | 10/03/2023SE |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5TMOS · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 09/01/2023SE |
| K231085 | 1.5T HD T/R Knee Array (10-F34127)MOS · Traditional | Shenzhen RF Tech Co., Ltd. | 08/18/2023SE |
| K223484 | IGAR System (1001.A)MOS · Traditional | Insight Medbotics, Inc. | 07/20/2023SE |
| K231647 | XENOVIEW 3.0T Chest CoilMOS · Special | Polarean, Inc. | 06/29/2023SE |
| K223225 | 8ch T/R Knee CoilMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 02/14/2023SE |
| K213480 | 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head CoilMOS · Traditional | Rapid Biomedical GmbH | 02/01/2023SE |
| K223429 | Contour KneeMOS · Traditional | Quality Electrodynamics, LLC | 01/13/2023SE |
| K223378 | 3.0T 16ch AIR AAMOS · Abbreviated | Ge Healthcare Coils (Usa Instruments, Inc.) | 01/03/2023SE |
| K212239 | XENOVIEW 3.0T Chest CoilMOS · Traditional | Polarean, Inc. | 12/23/2022SE |
| K223487 | InkSpace Imaging Body ArrayMOS · Special | Inkspace Imaging, Inc. | 12/08/2022SE |
| K223239 | 8ch Wrist CoilMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 12/08/2022SE |
| K222407 | 16ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T…MOS · Special | Neocoil, LLC | 10/14/2022SE |
| K222325 | 8ch Wrist CoilMOS · Traditional | Invivo Corporation (Business Trade Name: Philips) | 08/31/2022SE |
| K222257 | 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee CoilMOS · Traditional | Invivo Corporation (Business Trade Name: Philips) | 08/23/2022SE |
| K213735 | dS Sentinelle Breast 16ch 1.5T CoilMOS · Traditional | Invivo Corporation (Business Trade Name: Philips) | 08/08/2022SE |
| K213727 | dS Sentinelle Breast 16ch 3.0T CoilMOS · Traditional | Invivo Corporation (Business Trade Name: Philips) | 08/08/2022SE |
| K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3TMOS · Traditional | Noras Mri Products GmbH | 04/08/2022SE |
| K213687 | 32Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head…MOS · Traditional | Neocoil, LLC | 03/11/2022SE |
| K211658 | OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet…MOS · Traditional | Noras Mri Products GmbH | 03/03/2022SE |
| K213766 | dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and…MOS · Traditional | Invivo Corporation | 12/23/2021SE |
| K213397 | InkSpace Imaging Pediatric Body ArrayMOS · Traditional | Inkspace Imaging, Inc. | 12/17/2021SE |
| K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5TMOS · Traditional | Philips Healthcare (Suzhou) Co., Ltd. | 12/01/2021SE |
| K213351 | ds Head 32ch 3.0TMOS · Traditional | Invivo Corporation (Business Trade Name: Philips) | 10/29/2021SE |
| K200836 | 8ch Flex SuiteMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 07/22/2020SE |
| K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder CoilMOS · Traditional | Neocoil, LLC | 06/02/2020SE |
| K200477 | Flex Body SpeederMOS · Traditional | Quality Electrodynamics, LLC | 04/08/2020SE |
| K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil SupportMOS · Traditional | Rapid Biomedical GmbH | 01/31/2020SE |
| K193140 | Flex Body SPEEDERMOS · Traditional | Quality Electrodynamics, LLC | 01/03/2020SE |
| K190668 | Encompass 15 Channel Head Coil, 3TMOS · Traditional | Qfix | 09/09/2019SE |
| K182737 | 3T 32 Channel Head CoilMOS · Traditional | Nova Medical, Inc. | 04/12/2019SE |
| K183186 | Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4…MOS · Traditional | Shanghai United Imaging Healthcare Co., Ltd. | 02/08/2019SE |
| K183111 | Contour 24MOS · Traditional | Quality Electrodynamics, LLC | 12/07/2018SE |
| K182958 | 1.5T 16ch Breast CoilMOS · Traditional | Neocoil, LLC | 11/16/2018SE |
| K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast CoilMOS · Traditional | Rapid Biomedical GmbH | 11/16/2018SE |
| K182590 | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AAMOS · Traditional | GE Healthcare | 10/19/2018SE |
| K182504 | 3.0T Air MP M, 3.0T Air MP LMOS · Traditional | Ge Healthcare Coils (Usa Instruments, Inc.) | 10/12/2018SE |
| K181697 | 16ch Foot/ Ankle SPEEDERMOS · Traditional | Quality Electrodynamics, LLC | 07/11/2018SE |
| K180666 | 48CH Head CoilMOS · Special | Ge Healthcare Coils (Usa Instruments, Inc.) | 04/12/2018SE |
| K163661 | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex CoilMOS · Traditional | Rapid Biomedical GmbH | 03/21/2018SE |
| K180123 | Breast BI 7 MR Coil 1.5T MammaventionMOS · Traditional | Noras Mri Products GmbH | 02/16/2018SE |
| K173469 | 16ch T/R Hand Wrist CoilMOS · Traditional | Quality Electrodynamics, LLC | 01/09/2018SE |
| K172222 | 8ch Flex SuiteMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 12/08/2017SE |
| K173377 | 3.0T 16ch Breast CoilMOS · Traditional | Neocoil, LLC | 11/28/2017SE |
| K173290 | DuoFLEX Coil SuiteMOS · Traditional | Mr Instruments, Inc. | 11/28/2017SE |
| K172695 | AIR Anterior Array, AIR Posterior ArrayMOS · Traditional | Ge Healthcare Coils (Usa Instruments, Inc.) | 11/22/2017SE |
| K173446 | Contour 24MOS · Traditional | Quality Electrodynamics, LLC | 11/17/2017SE |
| K171515 | Nhac 16MOS · Special | Lmt Medical Systems GmbH | 07/26/2017SE |
| K162651 | Breast BI 7 MR Coil Mammavention 3TMOS · Traditional | Moras Mri Products GmbH | 01/18/2017SE |
| K163205 | 48CH Head CoilMOS · Traditional | Ge Healthcare Coils (Usa Instruments, Inc.) | 01/12/2017SE |
| K162946 | 8ch Knee-Foot SPEEDERMOS · Traditional | Quality Electrodynamics, LLC | 01/06/2017SE |
| K162623 | 16ch T/R Hand Wrist CoilMOS · Traditional | Quality Electrodynamics, LLC | 12/09/2016SE |
| K162966 | TxRx Knee 15 Flare MR Coil 1.5TMOS · Traditional | Quality Electrodynamics, LLC | 11/30/2016SE |
| K163066 | TxRx Knee 15 Flare MR Coil 3.0TMOS · Traditional | Quality Electrodynamics, LLC | 11/29/2016SE |
| K162863 | dS Small Extremity 16CH 1.5T CoilMOS · Traditional | Invivo Therapeutics Corporation | 11/07/2016SE |
| K162029 | 16ch T/R Knee CoilMOS · Traditional | Quality Electrodynamics, LLC | 10/18/2016SE |
| K162079 | TRILLIUM Oval Head Coil 32MOS · Traditional | Hitachi Medical Systems America, Inc. | 09/16/2016SE |
| K162177 | dS FootAnkle I6CH 1.5T CoilMOS · Traditional | Invivo Corporation | 09/14/2016SE |
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder CoilsMOS · Traditional | Invivo Corporation | 08/31/2016SE |
| K160932 | 8ch Foot Ankle CoilMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 08/01/2016SE |
| K160935 | 8ch Foot Ankle CoilMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 07/28/2016SE |
| K161193 | 16ch Tx/Rx Knee SPEEDERMOS · Traditional | Quality Electrodynamics, LLC | 06/02/2016SE |
| K152695 | 8 CH Knee SPEEDERMOS · Traditional | Quality Electrodynamics, LLC | 11/18/2015SE |
| K151753 | 16 ch Tx/Rx Knee SPEEDERMOS · Traditional | Quality Electrodynamics, LLC | 08/27/2015SE |
| K151653 | 8ch Foot Ankle CoilMOS · Traditional | Shenzhen RF Tech Co., Ltd. | 08/07/2015SE |
| K151829 | Atlas SPEEDER Header/NeckMOS · Traditional | Quality Electrodynamics, LLC | 07/29/2015SE |
| K150331 | 18ch T/R Knee CoilMOS · Traditional | Quality Electrodynamics, LLC | 04/09/2015SE |
| K143389 | 3.0T GEM RT Open ArrayMOS · Traditional | Ge Healthcare Coils (Usa Instruments, Inc.) | 03/06/2015SE |
| K142676 | Siemens 3.0T PROCURE Array CoilMOS · Special | Resonance Innovations, LLC | 12/05/2014SE |
| K142802 | Atlas SPEEDER Head/NeckMOS · Traditional | Quality Electrodynamics, LLC | 11/24/2014SE |
| K142755 | Siemens 3.0 Blanket Array CoilMOS · Traditional | Resonance Innovations, LLC | 10/23/2014SE |
| K142002 | Breast Speeder CX, Grid Holder CXMOS · Traditional | Quality Electrodynamics, LLC | 08/22/2014SE |
| K133506 | Noras or Head Holder FlexibilityMOS · Traditional | Noras Mri Products GmbH | 08/06/2014SE |
| K141832 | 3T 16CH Flex Speeder, Medium , 3T 16CH Flex Speeder, LargeMOS · Traditional | Neocoil, LLC | 07/31/2014SE |
| K140998 | Pediatric 16, A1.5T Tim Coil/Pediatric 16, A3T Tim CoilMOS · Traditional | Quality Electrodynamics, LLC | 07/11/2014SE |
| K140606 | 1.5T Procure Array Coil, 3.0T Procure Array CoilMOS · Special | Resonance Innovations, LLC | 05/12/2014SE |
| K140252 | 16 CH Multipurpose Coil VarietyMOS · Traditional | Noras Rontgen-Und Medizintechnik GmbH | 05/08/2014SE |
| K140282 | ST Sense NV 8 Array CoilMOS · Special | Resonance Innovations, LLC | 02/26/2014SE |
| K133986 | 1.5T Orbit and Mandible Array, 3.0T Orbit and Mandible ArrayMOS · Traditional | Resonance Innovations, LLC | 01/27/2014SE |
| K132444 | Atama SystemMOS · Traditional | Monteris Medical, | 01/27/2014SE |
| K133422 | 1.5T 16-CHANNEL Flex Coil, Small 1.5T 16-CHANNEL Flex Coil, LargeMOS · Abbreviated | Neocoil, LLC | 12/26/2013SE |
| K130706 | Duoflex Coil Suite (1.5T)MOS · Traditional | Mr Instruments, Inc. | 07/25/2013SE |
| K130457 | 3T Distal Coil, 3T Elbow Coil, 3T Long Bone CoilMOS · Special | Resonance Innovations, LLC | 05/20/2013SE |
| K123708 | Spine CoilMOS · Traditional | Usa Paramed Medical Systems, Inc. | 04/10/2013SE |
| K123272 | 1.5T 16CH Flex Speeder Large, 1.5T 16CH Flex Speeder MediumMOS · Abbreviated | Neocoil, LLC | 03/28/2013SE |
| K123681 | 1.5T 4CH Large Flex Coil, 1.5 4CH Small Flex CoilMOS · Traditional | Wipro GE Healthcare Private, Ltd. | 02/22/2013SE |
| K123327 | 1.5T Gem RT Open ArrayMOS · Traditional | Ge Healthcare Coils (Usa Instruments, Inc.) | 01/11/2013SE |
| K123091 | Visius Wireless Coils, 1.5T/ Visius Wireless Coils, 3TMOS · Traditional | Imris, Inc. | 12/27/2012SE |
| K122897 | Sense Head 16 Model 800647, Sense Spine 16 Model 800646; Sense Torso 16 Model 800645MOS · Traditional | Invivo Corporation | 12/21/2012SE |
| K123492 | DS Anterior, DS Base, DS Head-Neck, DS Head, Flex (S,M,L)MOS · Special | Philips Medical Systems | 12/13/2012SE |
| K122646 | DS Breast 16CH I/T 1.5T DS Breast 16CH I/T 3.0TMOS · Traditional | Invivo Corporation | 11/02/2012SE |
| K122694 | GE 8CH Foot Ankle CoilMOS · Traditional | Ge Hangwei Medical Systems Co., Ltd. | 10/25/2012SE |
| K122638 | Toshiba 3T 32CH Head Speeder Coil,MOS · Traditional | Quality Electrodynamics | 09/25/2012SE |
| K121911 | Octave Speeder SpineMOS · Special | Toshiba Medical Systems Corporation, Japan | 08/17/2012SE |
| K121910 | Octave Speeder HeadMOS · Special | Toshiba Medical Systems Corporation, Japan | 08/17/2012SE |
| K121362 | 1.5T 16CH Flex Speeder LargeMOS · Traditional | Neocoil, LLC | 06/15/2012SE |
| K121249 | Multiarray KitMOS · Special | Paramed S.R.L. | 06/12/2012SE |
| K120627 | Toshiba 1.5T QD Head CoilMOS · Traditional | Quality Electrodynamics | 03/29/2012SE |
| K113365 | Infant ArrayMOS · Traditional | Advanced Imaging Research Dba Sree Medical Systems | 03/29/2012SE |
| K113474 | 1.5T Gem Flex CoilMOS · Abbreviated | Neocoil, LLC | 03/16/2012SE |
| K120290 | Toshiba 1.5T Cardiac CoilMOS · Traditional | Quality Electrodynamics | 02/28/2012SE |
| K120122 | Sense MSK S 8CH 1.5TMOS · Special | Invivo Corporation | 02/10/2012SE |
| K111673 | 1.5T and 3T 8-CHANNEL Medium General Purpose Flex CoilMOS · Traditional | Invivo Corporation | 12/23/2011SE |
| K113280 | Carotid Coil GE 1.5TMOS · Traditional | Tursiop Technologies, LLC | 11/23/2011SE |
| K112002 | Carotid CoilMOS · Traditional | Shanghai Chenguang Medical Technologies Co, Ltd. | 11/18/2011SE |
| K112293 | HTS Extremity Coil, HTS Surface CoilMOS · Abbreviated | Time Medical Systems, Inc. | 09/30/2011SE |
| K112366 | 4CH Flex SpeederMOS · Special | Toshiba Medical Systems Coporation, Japan | 09/15/2011SE |
| K112313 | Toshiba 3T Extra Large Knee CoilMOS · Special | Quality Electrodynamics | 09/09/2011SE |
| K111060 | Mrgfus Pelvic Pa Coil Model 1.0MOS · Special | Insightech, Ltd. | 09/09/2011SE |
| K111802 | SV Brain Array, Siemens 3TMOS · Traditional | Mri Interventions, Inc. | 09/08/2011SE |
| K112112 | Sentinelle Breast MRI Tabletop with 16 Channel Coil Array for Siemens 1.5/3T MRI SystemsMOS · Special | Sentinel Medical, Inc. | 08/25/2011SE |
| K103274 | Sentinelle Endo Coil Array for Pelvic ImagingMOS · Traditional | Sentinelle Medical, Inc. | 08/18/2011SE |
| K111259 | SV DBS Vrain ArrayMOS · Traditional | Midwest Rf, LLC | 07/05/2011SE |
| K111251 | 4CH Flex SpeederMOS · Special | Toshiba Medical Systems Coporation, Japan | 05/27/2011SE |
| K102748 | 31P/1H Head Coil 3T; 23NA/1H Head Coil 3T; 13C/1H Head Coil 3TMOS · Abbreviated | Rapid Biomedical GmbH | 05/13/2011SE |
| K110487 | Flexible Cardiac CoilMOS · Traditional | Lbds Holding Company | 04/19/2011SE |
| K110411 | Atama SystemMOS · Traditional | Monteris Medical, Inc. | 04/08/2011SE |
| K110373 | Temporomanibular Coil 15MOS · Traditional | Esaote, S.p.A. | 04/06/2011SE |
| K110610 | 1.5 GE 6-CHANNEL Phased Array Flex Coil, 3.0 GE 6-CHANNEL Phased Array Flex CoilMOS · Special | Ge Medical Systems, LLC | 04/01/2011SE |
| K110591 | MC 1504G-16R, 1.5T, 16-CHANNEL, MC 3004G-16R, 3.0T, 16-CHANNEL Head CoilMOS · Traditional | Mr Instruments, Inc. | 03/29/2011SE |
| K103335 | Gem Option for 1.5 MRI SystemsMOS · Traditional | GE Healthcare | 03/07/2011SE |
| K110120 | Echelon Rapid Cardiac CoilMOS · Abbreviated | Hitachi Medical Systems America, Inc. | 02/25/2011SE |
| K103185 | Toshiba 1.5T Extra Large Knee CoilMOS · Traditional | Quality Electrodynamics | 02/25/2011SE |
| K103506 | 1.5T Head Coil (HC150), 3T Head Coil (HC300)MOS · Traditional | Imris, Inc. | 02/02/2011SE |
| K103365 | Discovery 3T 16 CH Body Array Coil (Anterior); Discovery 3T 16 CH Body Array Coil…MOS · Traditional | Ge Healthcare Coils (Usa Instruments, Inc.) | 01/12/2011SE |
| K103275 | Specialty Coils for Magnetom Aera 1.5T & Magnetim Skyra 3T MR SystemsMOS · Traditional | Siemens Medical Solutions USA, Inc. | 01/11/2011SE |
| K103149 | 1.5T 16-CHANNEL Hand-Wrist CoilMOS · Traditional | Invivo Corporation | 01/03/2011SE |
| K103342 | 3.0T MetaflexcoilMOS · Traditional | Neocoil, LLC | 12/23/2010SE |
| K102348 | 31P/1H Dual Tuned Surface Coil 3T; 23NA/ 1H Dual Turned Surface Coil 3T; 13C /1H Dual…MOS · Abbreviated | Rapid Biomedical GmbH | 12/22/2010SE |
| K102889 | Hitachi Echelon NV Attachment and Small Extremity Coils Model EchelonMOS · Traditional | Hitachi Medical Systems America, Inc. | 12/20/2010SE |
| K093689 | 1.5 Tesla 16- Channel Receive-Only Phased- Array Head Coil for SiemansMOS · Traditional | Mr Medical Solutions, LLC | 08/31/2010SE |
| K100141 | 14-CHANNEL Extremity Coil for Magnetom EssenzaMOS · Traditional | Siemens Medical Solutions USA, Inc. | 08/27/2010SE |
| K101632 | MetaflexcoilMOS · Traditional | Neocoil, LLC | 08/24/2010SE |
| K091047 | Neonate Array CoilsMOS · Traditional | Lmt Medical Systems GmbH | 08/18/2010SE |
| K101949 | Pediatric Body-Cardiac Coil, Model: 5000012601MOS · Traditional | Shanghai Chenguang Medical Technologies Co, Ltd. | 07/28/2010SE |
| K101858 | Pediatric Head-Spine Coil (MODEL:5000012701MOS · Traditional | Shanghai Chenguang Medical Technologies Co, Ltd. | 07/14/2010SE |
| K101492 | 8 Channel Cardiac Phased Array CoilMOS · Traditional | Ge Healthcare Coils (Usa Instruments, Inc.) | 06/23/2010SE |
| K100113 | Vanguard Breast MRI Auxiliary Table with 16 Channel Coil Array for GE 3T MRI System…MOS · Special | Sentinelle Medical, Inc. | 04/22/2010SE |
| K100670 | S-Scan, Model 9800020010MOS · Special | Esaote, S.p.A. | 04/05/2010SE |
| K093842 | 1.5T and 3.0T General Purpose Flex CoilsMOS · Traditional | Invivo Corporation | 03/05/2010SE |
| K093284 | 1.0T 8-CHANNEL Panorama Breast Array CoilMOS · Traditional | Invivo Corporation | 02/01/2010SE |
| K093667 | Shoulder Speeder CoilMOS · Traditional | Quality Electrodynamics | 01/28/2010SE |
| K093693 | Noras or Head Holder S17000-MQ/ Noras or Head Coil 3T 7230-PH Model S1700-MQ/ 7230-PHMOS · Traditional | Noras Mri Products GmbH | 01/19/2010SE |
| K093348 | 3.0T 16 Channel Head Neck Spine CoilMOS · Traditional | Ge Healthcare Coils (Usa Instruments, Inc.) | 11/25/2009SE |
| K092962 | Carotid Coil 5000004901MOS · Traditional | Shanghai Chenguang Medical Technologies Co, Ltd. | 10/09/2009SE |
| K091902 | 1.5T 8-CHANNEL Small Extremity Coil, Model 800494, 3.0T 8-CHANNEL Small Extremity Coil…MOS · Traditional | Invivo | 08/21/2009SE |
| K091546 | Noras or Head Coil 3T, Models SI7200/SI72100/SI7220/SI7230MOS · Special | Noras Mri Products GmbH | 06/24/2009SE |
| K091114 | TXRX 1.5T CP Head Coil; TXRX 3T CP Head CoilMOS · Traditional | Quality Electrodynamics | 05/01/2009SE |
| K083539 | Infant Cardiac ArrayMOS · Traditional | Advanced Imaging Research, Inc. | 04/03/2009SE |
| K090267 | SV DBS Brain Array, Model 1500SV-SMS64MOS · Traditional | Midwest Rf, LLC | 03/16/2009SE |
| K083541 | Neonate Head and Body CoilsMOS · Traditional | Advanced Imaging Research, Inc. | 02/24/2009SE |
| K083578 | Noras CPC Multifunctional CoilMOS · Abbreviated | Noras Mri Products GmbH | 01/16/2009SE |
| K083166 | Specialty Coils for the Magnetom EssenzaMOS · Traditional | Siemens Medical Solutions USA, Inc. | 01/13/2009SE |
| K083434 | TT1 General Purpose CoilMOS · Traditional | Tursiop Technologies, LLC | 12/23/2008SE |
| K083086 | Echelon High Resolution Foot Coil (MR-HRF-150), Echelon Long Bone Coil (MR-LBC-150)MOS · Traditional | Hitachi Medical Systems America, Inc. | 12/05/2008SE |
| K083255 | 16CH Ai Breast Coils 1.5 T and 3 TMOS · Traditional | Rapid Biomedical GmbH | 11/21/2008SE |
| K083160 | 1.5T Atlas Speeder Head-Neck CoilMOS · Traditional | Quality Electrodynamics | 11/07/2008SE |
| K082987 | HRK-63-16 Knee Array Coil, HRK-127-16 Knee Array CoilMOS · Special | Invivo | 11/06/2008SE |
| K083014 | Atlas Speeder Head/Cervical Coil, Model MJAH-137AMOS · Traditional | Toshiba America Medical Systems, In.C | 10/17/2008SE |
| K082916 | HRB-127-32 High Resolution Brain CoilMOS · Special | Invivo | 10/15/2008SE |
| K082636 | TXRX 15CH Knee Coil (1.5T and 3T), TXRX CP Extremity Coil 3TMOS · Traditional | Quality Electrodynamics | 09/25/2008SE |
| K082373 | Noras MR-BI320-PA 3TMOS · Abbreviated | Noras Mri Products GmbH | 08/29/2008SE |
| K081745 | Echelon Rapid PV Coil, Model MR-PVC-150, Echelon Rapid Foot Coil, Model MR-RFC-150 and…MOS · Traditional | Hitachi Medical Systems America, Inc. | 08/12/2008SE |
| K081340 | Pediatric Body and Cardiac Coil, Model 01000140201MOS · Traditional | Shanghai Chenguang Medical Technologies Co, Ltd. | 06/18/2008SE |
| K081322 | Magnetic Resonance Diagnostic Device, Model 0100140201, Pediatric Head-Spine CoilMOS · Traditional | Shanghai Chenguang Medical Technologies Co, Ltd. | 06/18/2008SE |
| K081198 | Echelon Rapid Head Coil, Model MR-RHC-150N, Echelon Rapid Torso Coil, Model MR-RBC-150NMOS · Traditional | Hitachi Medical Systems America, Inc. | 06/18/2008SE |
| K081118 | Noras MR-BI320-PA 1.5TMOS · Traditional | Noras Mri Products GmbH | 05/02/2008SE |
| K080820 | Tem 3002G- HN Dual Tune Head CoilMOS · Traditional | Mr Instruments, Inc. | 04/02/2008SE |
| K080120 | Hfo Shoulder CoilMOS · Traditional | Philips Medical Systems MR Finland | 03/10/2008SE |
| K080062 | Oasis Rapid Breast Coil, Model MR-IBC-120 and Oasis Rapid NV Coil, Model MR-NVC-120MOS · Traditional | Hitachi Medical Systems America, Inc. | 02/11/2008SE |
| K073310 | Oasis CTL Coil, Od Flexible Body Coil (L and XL), and Rapid Foot CoilMOS · Abbreviated | Hitachi Medical Corp. | 01/18/2008SE |
| K073131 | Micromri Wrist CoilMOS · Traditional | Micromri, Inc. | 01/18/2008SE |
| K073236 | Neocoil 3.0T 32-CHANNEL Torso Array Coil for GEMOS · Traditional | Neocoil | 11/30/2007SE |
| K073181 | Neocoil 1.5T 16 Channel Cardiac-Abdominal-Pelvic Array CoilMOS · Traditional | Neocoil, LLC | 11/21/2007SE |
| K072874 | LBS-127-16 Breast Array CoilMOS · Special | Invivo | 11/16/2007SE |
| K072873 | LBS-63-16 Breast Array CoilMOS · Special | Invivo | 11/16/2007SE |
| K072935 | Speeder 1.5T Wrist Array CoilMOS · Traditional | Quality Electrodynamics | 10/31/2007SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0548-2025 Class II | ST SENSE Breast Dx CoilPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0547-2025 Class II | ST SENSE Breast CoilPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0546-2025 Class II | SENSE Breast Coil 3.0T 7chPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0545-2025 Class II | SENSE Breast CoilPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0544-2025 Class II | Mammotrak Interventional Coil 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0543-2025 Class II | Mammotrak Diagnostic Coil 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0542-2025 Class II | Mammotrak Interventional Coil 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0541-2025 Class II | Mammotrak Diagnostic Coil 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0540-2025 Class II | dS Breast 7ch 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0539-2025 Class II | dS Breast 7ch 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0538-2025 Class II | dS Breast 16ch 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0537-2025 Class II | dS Breast 16ch 1.5TPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-0536-2025 Class II | Achieva TX Interventional Coil 3.0TPotential safety issue where a patient may be harmed while preparing for or during a scan. | Philips North America Llc | 11/04/2024Open, Classified |
| Z-2165-2024 Class I | SENSE XL TORSO COIL 1.5T Mk2. 16-element receive only coil for torso and abdomen imaging…Potential for coils to heat up and harm patients (burn). | Philips North America Llc | 06/05/2024Open, Classified |
| Z-2164-2024 Class I | SENSE XL TORSO COIL 3.0T. 16-element receive only coil for torso and abdomen imaging in…Potential for coils to heat up and harm patients (burn). | Philips North America Llc | 06/05/2024Open, Classified |
| Z-2163-2024 Class I | SENSE XL TORSO COIL 1.5T. 16-element receive only coil for torso and abdomen imaging in…Potential for coils to heat up and harm patients (burn). | Philips North America Llc | 06/05/2024Open, Classified |
| Z-0126-2021 Class III | MR Coils The MR Coil is intended to be used in conjunction with a Magnetic Resonance…The labels have been mistakenly printed with an IPX1 rating symbol. IPX ratings relate to protections that… | Invivo Corporation | 09/14/2020Terminated |
| Z-0037-2020 Class II | TxRx Knee 15 Coil 1.5T QED part number: Q7000057 Siemens Model # 10606829Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | Quality Electrodynamics LLC | 08/20/2019Terminated |
| Z-0036-2020 Class II | TxRx Knee 15 Coil 1.5T QED part number: Q7000056 Siemens Model # 10606828Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | Quality Electrodynamics LLC | 08/20/2019Terminated |
| Z-0035-2020 Class II | TxRx 15CH Knee Coil 3T QED part number: Q7000051 Siemens Model # 10606525Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | Quality Electrodynamics LLC | 08/20/2019Terminated |
| Z-0034-2020 Class II | TxRx 15CH Knee Coil 1.5T QED part number: Q7000050 Siemens Model # 10606524Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | Quality Electrodynamics LLC | 08/20/2019Terminated |
| Z-0033-2020 Class II | TxRx CP Extremity Coil 3T QED part number: Q7000019 Siemens Model # 10185464Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | Quality Electrodynamics LLC | 08/20/2019Terminated |
| Z-0032-2020 Class II | TxRx 15CH Knee Coil 1.5T QED part number:Q7000016 Siemens Model # 10185453Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | Quality Electrodynamics LLC | 08/20/2019Terminated |
| Z-0031-2020 Class II | TxRx 15Ch Knee Coil 3T QED part number:Q7000008 Siemens Model # 10185460Unintended ferrous material may be present within the pushbutton assembly of Siemens Knee and Siemens… | Quality Electrodynamics LLC | 08/20/2019Terminated |
| Z-0062-2020 Class II | AIR Technology Anterior Array, Catalogue Numbers: (a) 5746694, (b) 5746695, (c) 5746696…The outer seam of the coil, closest to the system cable, may separate and expose the porous material… | GE Healthcare, LLC | 03/19/2019Terminated |
| Z-2312-2016 Class II | 3T 16ch Flex SPEEDER Coil, Large, NeoCoil Part Number NC046200, Toshiba Medical Systems…There is a potential for higher than specified surface temperatures involving the 3T 16ch Flex SPEEDER Large… | NeoCoil, LLC | 06/17/2016Terminated |
| Z-2688-2016 Class II | Invivo Sentinelle Venguard Breast MRI Auxiliary Table/Tabletop with 8/16 Channel Coil…A diode was inadvertently not assembled into the system, which may result in coil overheating | Invivo Corporation | 05/06/2016Terminated |
| Z-1027-2016 Class II | NeoCoil 3.0T GEM Flex Coil. The 3.0T GEM Flex coil system includes three sizes of coil…Potential for higher than specified surface temperatures. Use of 3.0T GEM Flex system may result in patient… | NeoCoil, LLC | 12/18/2015Terminated |
| Z-0553-2016 Class II | GE Healthcare, 3.0T 6 Channel Phased Array Flex Coil, M0050SS. Product Usage The 3.0T GE…Coil overheating can occur when the device is used in Mode 2 setup. This could lead to a serious patient… | GE Medical Systems, LLC | 12/07/2015Terminated |
| Z-2366-2015 Class II | Oasis Coil Extension Cable used with Hitachi Oasis MRI System Product Usage: The Oasis…The firm received a complaint stating the Coil Extension Cable accessory would overheat and be a burn hazard… | Hitachi Medical Systems America Inc | 04/25/2014Terminated |
| Z-2314-2012 Class II | TxRx Knee 15 Coil 3T. For use in conjunction with magnetic resonance scanners to produce…On July 27, 2012, it was reported to the firm that the Siemens 3T 15ch Knee Coil was not functional because… | Quality Electrodynamics LLC | 07/27/2012Terminated |
| Z-1492-2012 | GE Healthcare, Optima MR450W with GEM. Product Usage - The GEM Option for 1 .5T MRI…GE Healthcare is conducting a recall on Optima MR450W with GEM. During scanning of a patient, if an… | GE Healthcare, LLC | 04/12/2012Terminated |
| Z-1616-2010 | Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers:…Hitachi determined that the mounting method for a Compensation Coil did not include an appropriate factor of… | Hitachi Medical Systems America Inc | 04/19/2010Terminated |
| Z-1938-2009 | Mirror assembly to magnetic resonance device (1.5T Atlas SPEEDER Head-Neck Coil) Coil…The firm received a complaint indicating that the mirror is high risk and could drop on a patient. | Quality Electrodynamics Llc | 12/29/2008Terminated |
| Z-2461-2010 | Nuclear Magnetic Resonance Imaging System (MRI). Trace item 9896-030-14351 -1.5T Sense…The cables of the coil may become too hot and cause burns when placed too close to the patient. While using… | Philips Medical Systems North America Co.… | 09/30/2008Terminated |
| Z-0164-2007 | 3.0T HD Head Neck Spine Array, Model 2415545, for GE 3.0T Excite MR System.The firm determined that certain potential conditions for use of their medical device, outside of… | USA Instruments Incorporated | 09/20/2006Terminated |
| Z-0163-2007 | 1.5T HD Head Neck Spine Array, Model 2416329, for GE 1.5T Excite MR System.The firm determined that certain potential conditions for use of their medical device, outside of… | USA Instruments Incorporated | 09/20/2006Terminated |
| Z-0152-2007 | Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with…Component defect/overheating device; A malfunctioning decoupling circuit in the CTL coil caused high current… | Hitachi Medical Systems America Inc | 08/14/2006Terminated |