FDA Product Code
FDA Product Code MOS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1000
510(k) Clearances — 490 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262330 | dS Breast 7ch 1.5TdS Breast 7ch 3.0TdS Breast 16ch 1.5TdS Breast 16ch 3.0TdS Breast Coil 7ch 1.5TdS Sentinelle Breast 16ch 1.5TdS Sentinelle Breast 16ch 3.0T | Philips Medical Systems Nederland B.V. | 2026-07-30 | Special | PDF ↗ |
| K262294 | dS 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 Extremity 16Ch 1.5T;dS Small Extremity 16Ch 3.0T | Philips Medical Systems Nederland B.V. | 2026-07-24 | Special | PDF ↗ |
| K260947 | 0.55T 12Ch Breast Coil | Neocoil, LLC | 2026-04-23 | Special | PDF ↗ |
| K252587 | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | 2026-04-14 | Traditional | PDF ↗ |
| 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 | Shenzhen RF Tech Co., Ltd. | 2026-04-01 | Traditional | PDF ↗ |
| K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-20 | Special | PDF ↗ |
| 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 | Shenzhen RF Tech Co., Ltd. | 2026-02-10 | Traditional | PDF ↗ |
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2026-01-23 | Abbreviated | PDF ↗ |
| 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 | Philips Medical Systems Nederland B.V. | 2026-01-14 | Special | PDF ↗ |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | 2025-10-20 | Special | PDF ↗ |
| K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical, Inc. | 2025-07-17 | Abbreviated | PDF ↗ |
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Quality Electrodynamics | 2025-02-28 | Traditional | PDF ↗ |
| K243675 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024-12-20 | Special | PDF ↗ |
| K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2024-11-19 | Special | PDF ↗ |
| K243033 | dS Wrist coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-10-18 | Special | PDF ↗ |
| K242879 | dS Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-10-18 | Special | PDF ↗ |
| K242096 | dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-08-12 | Special | PDF ↗ |
| K241069 | iLoop Interventional Coil 0.55T | Noras Mri Products GmbH | 2024-06-07 | Abbreviated | PDF ↗ |
| K233652 | Contour Hand/Wrist (Q7000232) | Quality Electrodynamics | 2024-02-16 | Traditional | PDF ↗ |
| K233656 | Contour Shoulder | Quality Electrodynamics | 2024-02-15 | Traditional | PDF ↗ |
| K233600 | Smart Fit Knee 3.0T | Philips Healthcare (Suzhou) Co., Ltd. | 2024-02-05 | Traditional | PDF ↗ |
| K233444 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024-01-08 | Special | PDF ↗ |
| K233348 | 16 Breast Coil | Philips Medical System Nederlands B.V. | 2023-10-24 | Special | PDF ↗ |
| K232762 | dS Breast Coil 7ch 1.5T | Invivo Corporation (Business Trade Name: Philips) | 2023-10-03 | Special | PDF ↗ |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2023-09-01 | Traditional | PDF ↗ |
| K231085 | 1.5T HD T/R Knee Array (10-F34127) | Shenzhen RF Tech Co., Ltd. | 2023-08-18 | Traditional | PDF ↗ |
| K223484 | IGAR System (1001.A) | Insight Medbotics, Inc. | 2023-07-20 | Traditional | PDF ↗ |
| K231647 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2023-06-29 | Special | PDF ↗ |
| K223225 | 8ch T/R Knee Coil | Shenzhen RF Tech Co., Ltd. | 2023-02-14 | Traditional | PDF ↗ |
| K213480 | 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil | Rapid Biomedical GmbH | 2023-02-01 | Traditional | PDF ↗ |
| K223429 | Contour Knee | Quality Electrodynamics, LLC | 2023-01-13 | Traditional | PDF ↗ |
| K223378 | 3.0T 16ch AIR AA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2023-01-03 | Abbreviated | PDF ↗ |
| K212239 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2022-12-23 | Traditional | PDF ↗ |
| K223239 | 8ch Wrist Coil | Shenzhen RF Tech Co., Ltd. | 2022-12-08 | Traditional | PDF ↗ |
| K223487 | InkSpace Imaging Body Array | Inkspace Imaging, Inc. | 2022-12-08 | Special | PDF ↗ |
| 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 | Neocoil, LLC | 2022-10-14 | Special | PDF ↗ |
| K222325 | 8ch Wrist Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-31 | Traditional | PDF ↗ |
| K222257 | 1.5 T/R Quad Extremity Coil, 1.5T 8CH T/R Knee Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-23 | Traditional | PDF ↗ |
| K213727 | dS Sentinelle Breast 16ch 3.0T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-08 | Traditional | PDF ↗ |
| K213735 | dS Sentinelle Breast 16ch 1.5T Coil | Invivo Corporation (Business Trade Name: Philips) | 2022-08-08 | Traditional | PDF ↗ |
| K220144 | Breast BI Coil Set 0.55T; Breast BI 7 MR Coil Set 1.5T; Breast BI 7 MR Coil Set 3T | Noras Mri Products GmbH | 2022-04-08 | Traditional | PDF ↗ |
| 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 | Neocoil, LLC | 2022-03-11 | Traditional | PDF ↗ |
| 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 | Noras Mri Products GmbH | 2022-03-03 | Traditional | PDF ↗ |
| 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 | Invivo Corporation | 2021-12-23 | Traditional | PDF ↗ |
| K213397 | InkSpace Imaging Pediatric Body Array | Inkspace Imaging, Inc. | 2021-12-17 | Traditional | PDF ↗ |
| K212864 | dS TorsoCardiac 1.5T, dS MSK S 1.5T, dS MSK M 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2021-12-01 | Traditional | PDF ↗ |
| K213351 | ds Head 32ch 3.0T | Invivo Corporation (Business Trade Name: Philips) | 2021-10-29 | Traditional | PDF ↗ |
| K200836 | 8ch Flex Suite | Shenzhen RF Tech Co., Ltd. | 2020-07-22 | Traditional | PDF ↗ |
| K201101 | 1.5T 16ch Shoulder Coil, 3.0T 16ch Shoulder Coil | Neocoil, LLC | 2020-06-02 | Traditional | PDF ↗ |
| K200477 | Flex Body Speeder | Quality Electrodynamics, LLC | 2020-04-08 | Traditional | PDF ↗ |
| K191539 | 1.5T Endorectal Coil, 3.0T Endorectal Coil, ER Coil Support | Rapid Biomedical GmbH | 2020-01-31 | Traditional | PDF ↗ |
| K193140 | Flex Body SPEEDER | Quality Electrodynamics, LLC | 2020-01-03 | Traditional | PDF ↗ |
| K190668 | Encompass 15 Channel Head Coil, 3T | Qfix | 2019-09-09 | Traditional | PDF ↗ |
| K182737 | 3T 32 Channel Head Coil | Nova Medical, Inc. | 2019-04-12 | Traditional | PDF ↗ |
| K183186 | Head Coil 12, Head Coil 32, Carotid Coil 8, Temporomandibular Joint Coil 4, Infant Coil 24, Cardiac Coil 24, Foot & Ankle Coil - 24 | Shanghai United Imaging Healthcare Co., Ltd. | 2019-02-08 | Traditional | PDF ↗ |
| K183111 | Contour 24 | Quality Electrodynamics, LLC | 2018-12-07 | Traditional | PDF ↗ |
| K182958 | 1.5T 16ch Breast Coil | Neocoil, LLC | 2018-11-16 | Traditional | PDF ↗ |
| K181948 | 1.5T 16Ch Diagnostic Breast Coil, 3.0T 16Ch Diagnostic Breast Coil | Rapid Biomedical GmbH | 2018-11-16 | Traditional | PDF ↗ |
| K182590 | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA | GE Healthcare | 2018-10-19 | Traditional | PDF ↗ |
| K182504 | 3.0T Air MP M, 3.0T Air MP L | Ge Healthcare Coils (Usa Instruments, Inc.) | 2018-10-12 | Traditional | PDF ↗ |
| K181697 | 16ch Foot/ Ankle SPEEDER | Quality Electrodynamics, LLC | 2018-07-11 | Traditional | PDF ↗ |
| K180666 | 48CH Head Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2018-04-12 | Special | PDF ↗ |
| K163661 | P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil | Rapid Biomedical GmbH | 2018-03-21 | Traditional | PDF ↗ |
| K180123 | Breast BI 7 MR Coil 1.5T Mammavention | Noras Mri Products GmbH | 2018-02-16 | Traditional | PDF ↗ |
| K173469 | 16ch T/R Hand Wrist Coil | Quality Electrodynamics, LLC | 2018-01-09 | Traditional | PDF ↗ |
| K172222 | 8ch Flex Suite | Shenzhen RF Tech Co., Ltd. | 2017-12-08 | Traditional | PDF ↗ |
| K173377 | 3.0T 16ch Breast Coil | Neocoil, LLC | 2017-11-28 | Traditional | PDF ↗ |
| K173290 | DuoFLEX Coil Suite | Mr Instruments, Inc. | 2017-11-28 | Traditional | PDF ↗ |
| K172695 | AIR Anterior Array, AIR Posterior Array | Ge Healthcare Coils (Usa Instruments, Inc.) | 2017-11-22 | Traditional | PDF ↗ |
| K173446 | Contour 24 | Quality Electrodynamics, LLC | 2017-11-17 | Traditional | PDF ↗ |
| K171515 | NHAC 16 | Lmt Medical Systems GmbH | 2017-07-26 | Special | PDF ↗ |
| K162651 | Breast BI 7 MR Coil Mammavention 3T | Moras Mri Products GmbH | 2017-01-18 | Traditional | PDF ↗ |
| K163205 | 48CH Head Coil | Ge Healthcare Coils (Usa Instruments, Inc.) | 2017-01-12 | Traditional | PDF ↗ |
| K162946 | 8ch Knee-Foot SPEEDER | Quality Electrodynamics, LLC | 2017-01-06 | Traditional | PDF ↗ |
| K162623 | 16ch T/R Hand Wrist Coil | Quality Electrodynamics, LLC | 2016-12-09 | Traditional | PDF ↗ |
| K162966 | TxRx Knee 15 Flare MR Coil 1.5T | Quality Electrodynamics, LLC | 2016-11-30 | Traditional | PDF ↗ |
| K163066 | TxRx Knee 15 Flare MR Coil 3.0T | Quality Electrodynamics, LLC | 2016-11-29 | Traditional | PDF ↗ |
| K162863 | dS Small Extremity 16CH 1.5T Coil | Invivo Therapeutics Corporation | 2016-11-07 | Traditional | PDF ↗ |
| K162029 | 16ch T/R Knee Coil | Quality Electrodynamics, LLC | 2016-10-18 | Traditional | PDF ↗ |
| K162079 | TRILLIUM Oval Head Coil 32 | Hitachi Medical Systems America, Inc. | 2016-09-16 | Traditional | PDF ↗ |
| K162177 | dS FootAnkle I6CH 1.5T Coil | Invivo Corporation | 2016-09-14 | Traditional | PDF ↗ |
| K162001 | 1.5T and 3.0T 16 CH GE Shoulder Coils | Invivo Corporation | 2016-08-31 | Traditional | PDF ↗ |
| K160932 | 8ch Foot Ankle Coil | Shenzhen RF Tech Co., Ltd. | 2016-08-01 | Traditional | PDF ↗ |
| K160935 | 8ch Foot Ankle Coil | Shenzhen RF Tech Co., Ltd. | 2016-07-28 | Traditional | PDF ↗ |
| K161193 | 16ch Tx/Rx Knee SPEEDER | Quality Electrodynamics, LLC | 2016-06-02 | Traditional | PDF ↗ |
| K152695 | 8 CH Knee SPEEDER | Quality Electrodynamics, LLC | 2015-11-18 | Traditional | PDF ↗ |
| K151753 | 16 ch Tx/Rx Knee SPEEDER | Quality Electrodynamics, LLC | 2015-08-27 | Traditional | PDF ↗ |
| K151653 | 8ch Foot Ankle Coil | Shenzhen RF Tech Co., Ltd. | 2015-08-07 | Traditional | PDF ↗ |
| K151829 | Atlas SPEEDER Header/Neck | Quality Electrodynamics, LLC | 2015-07-29 | Traditional | PDF ↗ |
| K150331 | 18ch T/R Knee Coil | Quality Electrodynamics, LLC | 2015-04-09 | Traditional | PDF ↗ |
| K143389 | 3.0T GEM RT Open Array | Ge Healthcare Coils (Usa Instruments, Inc.) | 2015-03-06 | Traditional | PDF ↗ |
| K142676 | Siemens 3.0T PROCURE Array Coil | Resonance Innovations, LLC | 2014-12-05 | Special | PDF ↗ |
| K142802 | Atlas SPEEDER Head/Neck | Quality Electrodynamics, LLC | 2014-11-24 | Traditional | PDF ↗ |
| K142755 | Siemens 3.0 Blanket Array Coil | Resonance Innovations, LLC | 2014-10-23 | Traditional | PDF ↗ |
| K142002 | BREAST SPEEDER CX, GRID HOLDER CX | Quality Electrodynamics, LLC | 2014-08-22 | Traditional | PDF ↗ |
| K133506 | NORAS OR HEAD HOLDER FLEXIBILITY | Noras Mri Products GmbH | 2014-08-06 | Traditional | PDF ↗ |
| K141832 | 3T 16CH FLEX SPEEDER, MEDIUM , 3T 16CH FLEX SPEEDER, LARGE | Neocoil, LLC | 2014-07-31 | Traditional | PDF ↗ |
| K140998 | PEDIATRIC 16, A1.5T TIM COIL/PEDIATRIC 16, A3T TIM COIL | Quality Electrodynamics, LLC | 2014-07-11 | Traditional | PDF ↗ |
| K140606 | 1.5T PROCURE ARRAY COIL, 3.0T PROCURE ARRAY COIL | Resonance Innovations, LLC | 2014-05-12 | Special | PDF ↗ |
| K140252 | 16 CH MULTIPURPOSE COIL VARIETY | Noras Rontgen-Und Medizintechnik GmbH | 2014-05-08 | Traditional | PDF ↗ |
Product code MOS · Class II · Radiology. Data: openFDA.