ClearanceBrief
Panels › Radiology › Product code MOS · Class 2

Coil, Magnetic Resonance, Specialty

Regulation 892.1000

10510(k)s in 12 months (491 all time)
0recalls in 12 months (38 all time)
37recalls that name a 510(k)
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Top companies in MOS

Company510(k)sRecalls
Usa Instruments, Inc.632
Mri Devices Corp.650
Quality Electrodynamics339
Invivo212
Hitachi Medical Systems America, Inc.183
GE Medical Systems191
Neocoil182
Medical Advances, Inc.190
Medrad, Inc.180
Philips North America Llc016
Decided510(k)Device and applicantCode
Oct 5, 2026K262813InkSpace Imaging Small Body Array (SBA12PH15x)
Inkspace Imaging, Inc.
MOS
Jul 30, 2026K262330dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16
Philips Medical Systems Nederland B.V., NL
MOS
Jul 24, 2026K262294dS FootAnkle 16Ch 1.5T;dS FootAnkle 16Ch 3.0T;dS HiRes Hand/Wrist 16Ch 1.5T;dS HiRes Hand/Wrist 16CH 3.0T;dS Small Extre
Philips Medical Systems Nederland B.V., NL
MOS
Apr 23, 2026K2609470.55T 12Ch Breast Coil
Neocoil, LLC
MOS
Apr 14, 2026K252587HD 8Ch Wrist Array
Shenzhen RF Tech Co., Ltd., CN
MOS
Apr 1, 2026K252876GEM 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
Shenzhen RF Tech Co., Ltd., CN
MOS
Mar 20, 2026K260519Smart Fit TorsoCardiac 1.5T
Philips Healthcare (Suzhou) Co., Ltd., CN
MOS
Feb 10, 2026K252179GEM 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
Shenzhen RF Tech Co., Ltd., CN
MOS
Jan 23, 2026K2537383.0T AIR 32CH HNA
Ge Healthcare Coils (Usa Instruments, Inc.)
MOS
Jan 14, 2026K254190dS Base 1.5T; dS Base 3.0T; dS Head 1.5T; dS Head 3.0T; dS HeadNeck 1.5T; dS HeadNeck 3.0T
Philips Medical Systems Nederland B.V., NL
MOS
Oct 20, 2025K253182InkSpace Imaging Small Body Array (SBA12PH30x)
Inkspace Imaging, Inc.
MOS
Jul 17, 2025K243428e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector
Dxtx Medical, Inc.
MOS
Feb 28, 2025K24405416ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247)
Quality Electrodynamics
MOS
Dec 20, 2024K243675InkSpace Imaging Small Body Array
Inkspace Imaging, Inc.
MOS
Nov 19, 2024K243316XENOVIEW 3.0T Chest Coil
Polarean, Inc.
MOS
Oct 18, 2024K243033dS Wrist coil 8ch 1.5T
Philips Medical Systems Nederland B.V., NL
MOS
Oct 18, 2024K242879dS Knee Coil 8ch 1.5T
Philips Medical Systems Nederland B.V., NL
MOS
Aug 12, 2024K242096dS FootAnkle Coil 8ch 1.5T
Philips Medical Systems Nederland B.V., NL
MOS
Jun 7, 2024K241069iLoop Interventional Coil 0.55T
Noras Mri Products GmbH, DE
MOS
Feb 16, 2024K233652Contour Hand/Wrist (Q7000232)
Quality Electrodynamics
MOS
Feb 15, 2024K233656Contour Shoulder
Quality Electrodynamics
MOS
Feb 5, 2024K233600Smart Fit Knee 3.0T
Philips Healthcare (Suzhou) Co., Ltd., CN
MOS
Jan 8, 2024K233444InkSpace Imaging Small Body Array
Inkspace Imaging, Inc.
MOS
Oct 24, 2023K23334816 Breast Coil
Philips Medical System Nederlands B.V., NL
MOS
Oct 3, 2023K232762dS Breast Coil 7ch 1.5T
Invivo Corporation (Business Trade Name: Philips)
MOS
Sep 1, 2023K232021Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T
Philips Healthcare (Suzhou) Co., Ltd., CN
MOS
Aug 18, 2023K2310851.5T HD T/R Knee Array (10-F34127)
Shenzhen RF Tech Co., Ltd., CN
MOS
Jul 20, 2023K223484IGAR System (1001.A)
Insight Medbotics, Inc., CA
MOS
Jun 29, 2023K231647XENOVIEW 3.0T Chest Coil
Polarean, Inc.
MOS
Feb 14, 2023K2232258ch T/R Knee Coil
Shenzhen RF Tech Co., Ltd., CN
MOS
Feb 1, 2023K21348031P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil
Rapid Biomedical GmbH, DE
MOS
Jan 13, 2023K223429Contour Knee
Quality Electrodynamics, LLC
MOS
Jan 3, 2023K2233783.0T 16ch AIR AA
Ge Healthcare Coils (Usa Instruments, Inc.)
MOS
Dec 23, 2022K212239XENOVIEW 3.0T Chest Coil
Polarean, Inc.
MOS
Dec 8, 2022K223487InkSpace Imaging Body Array
Inkspace Imaging, Inc.
MOS
Dec 8, 2022K2232398ch Wrist Coil
Shenzhen RF Tech Co., Ltd., CN
MOS
Oct 14, 2022K22240716ch Breast Coil / 16ch Breast Coils, 1.5T 16ch Breast Coil, 3.0T 16ch Breast Coil, 1.5T 16ch Breast Coil, 3T 16ch Breas
Neocoil, LLC
MOS
Aug 31, 2022K2223258ch Wrist Coil
Invivo Corporation (Business Trade Name: Philips)
MOS
Aug 23, 2022K2222571.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil
Invivo Corporation (Business Trade Name: Philips)
MOS
Aug 8, 2022K213735dS Sentinelle Breast 16ch 1.5T Coil
Invivo Corporation (Business Trade Name: Philips)
MOS
Aug 8, 2022K213727dS Sentinelle Breast 16ch 3.0T Coil
Invivo Corporation (Business Trade Name: Philips)
MOS
Apr 8, 2022K220144Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T
Noras Mri Products GmbH, DE
MOS
Mar 11, 2022K21368732Ch AIR Open Coil Suite: 1.5T AIR Open Head Neck Posterior 9ch / 3.0T AIR Open Head Neck Posterior 9ch, 1.5T AIR Open N
Neocoil, LLC
MOS
Mar 3, 2022K211658OR Head Holder LUCY with HeadCoilSet Siemens 1.5T, OR Head Holder LUCY with HeadCoilSet Siemens 3T, OR Head Holder LUCY
Noras Mri Products GmbH, DE
MOS
Dec 23, 2021K213766dS FootAnkle 16Ch Coils for 1.5T and 3.0T, dS HiRes HandWrist 16Ch Coils for 1.5T and 3.0T, ds Small Extremity 16Ch Coil
Invivo Corporation
MOS
Dec 17, 2021K213397InkSpace Imaging Pediatric Body Array
Inkspace Imaging, Inc.
MOS
Dec 1, 2021K212864dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T
Philips Healthcare (Suzhou) Co., Ltd., CN
MOS
Oct 29, 2021K213351ds Head 32ch 3.0T
Invivo Corporation (Business Trade Name: Philips)
MOS
Jul 22, 2020K2008368ch Flex Suite
Shenzhen RF Tech Co., Ltd., CN
MOS
Jun 2, 2020K2011011.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil
Neocoil, LLC
MOS

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