Product code MOS
- Device name
- Coil, Magnetic Resonance, Specialty
- Medical specialty
- Radiology
- Device class
- 2
- Regulation number
- 892.1000
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K260947 | 0.55T 12Ch Breast Coil | Neocoil, LLC | 2026-04-23 |
| K252587 | HD 8Ch Wrist Array | Shenzhen RF Tech Co., Ltd. | 2026-04-14 |
| 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 |
| K260519 | Smart Fit TorsoCardiac 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2026-03-20 |
| 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 |
| K253738 | 3.0T AIR 32CH HNA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2026-01-23 |
| 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 |
| K253182 | InkSpace Imaging Small Body Array (SBA12PH30x) | Inkspace Imaging, Inc. | 2025-10-20 |
| K243428 | e2CoilTM Imaging System for the Siemens MAGNETOM 3.0T MRI Systems with Tim 4G Connector | Dxtx Medical, Inc. | 2025-07-17 |
| K244054 | 16ch Flex SPEEDER Medium 1.5T (Q7000246); 16ch Flex SPEEDER Large 1.5T (Q7000247) | Quality Electrodynamics | 2025-02-28 |
| K243675 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024-12-20 |
| K243316 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2024-11-19 |
| K243033 | dS Wrist coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-10-18 |
| K242879 | dS Knee Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-10-18 |
| K242096 | dS FootAnkle Coil 8ch 1.5T | Philips Medical Systems Nederland B.V. | 2024-08-12 |
| K241069 | iLoop Interventional Coil 0.55T | Noras Mri Products GmbH | 2024-06-07 |
| K233652 | Contour Hand/Wrist (Q7000232) | Quality Electrodynamics | 2024-02-16 |
| K233656 | Contour Shoulder | Quality Electrodynamics | 2024-02-15 |
| K233600 | Smart Fit Knee 3.0T | Philips Healthcare (Suzhou) Co., Ltd. | 2024-02-05 |
| K233444 | InkSpace Imaging Small Body Array | Inkspace Imaging, Inc. | 2024-01-08 |
| K233348 | 16 Breast Coil | Philips Medical System Nederlands B.V. | 2023-10-24 |
| K232762 | dS Breast Coil 7ch 1.5T | Invivo Corporation (Business Trade Name: Philips) | 2023-10-03 |
| K232021 | Smart Fit TorsoCardiac 1.5T and Smart Fit Shoulder 1.5T | Philips Healthcare (Suzhou) Co., Ltd. | 2023-09-01 |
| K231085 | 1.5T HD T/R Knee Array (10-F34127) | Shenzhen RF Tech Co., Ltd. | 2023-08-18 |
| K223484 | IGAR System (1001.A) | Insight Medbotics, Inc. | 2023-07-20 |
| K231647 | XENOVIEW 3.0T Chest Coil | Polarean, Inc. | 2023-06-29 |
| K223225 | 8ch T/R Knee Coil | Shenzhen RF Tech Co., Ltd. | 2023-02-14 |
| K213480 | 31P/1H Head Coil, 23Na/1H Head Coil, 13C/1H Head Coil | Rapid Biomedical GmbH | 2023-02-01 |
| K223429 | Contour Knee | Quality Electrodynamics, LLC | 2023-01-13 |
| K223378 | 3.0T 16ch AIR AA | Ge Healthcare Coils (Usa Instruments, Inc.) | 2023-01-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00195278925282 | NA | GE HEALTHCARE(TIANJIN) COMPANY LIMITED | 2026-05-11 |
| 04260486610605 | NBAC 1.5T GE P Spine | LMT Medical Systems GmbH | 2026-04-28 |
| 04260486610339 | NBAC 3.0T PH I Flex | LMT Medical Systems GmbH | 2026-04-28 |
| 00195278929518 | NA | GE HEALTHCARE(TIANJIN) COMPANY LIMITED | 2025-09-26 |
| 00195278483713 | NA | GE Medical Systems, L.L.C. | 2025-05-07 |
| 04260486610483 | NHAC 1.5T PH I 16 | LMT Medical Systems GmbH | 2024-04-23 |
| 04260486610537 | NHAC 3.0T PH I 16 | LMT Medical Systems GmbH | 2024-04-23 |
| 04260486610582 | NBAC 1.5T PH I Spine | LMT Medical Systems GmbH | 2024-04-23 |
| 04260486610599 | NBAC 3.0T PH I Spine | LMT Medical Systems GmbH | 2024-04-23 |
| 08056304455055 | S-scan Open | ESAOTE SPA | 2023-12-14 |
| 04260486610957 | NBAC 1.5T PH I Flex | LMT Medical Systems GmbH | 2023-06-01 |
| 04260486610940 | NBAC 1.5T SMS, Flex | LMT Medical Systems GmbH | 2023-06-01 |
| 00195278481382 | NA | GE HEALTHCARE(TIANJIN) COMPANY LIMITED | 2022-09-08 |
| 04260486610544 | NHAC 3.0T GE P 16 | LMT Medical Systems GmbH | 2022-02-14 |
| 04260486610612 | NBAC 3.0T GE P, Spine | LMT Medical Systems GmbH | 2022-02-14 |
| 04260486610377 | NBAC 3.0T GE H, Flex | LMT Medical Systems GmbH | 2022-02-14 |
| 04260486610636 | NBAC 3.0T SMS, Spine | LMT Medical Systems GmbH | 2021-12-08 |
| 04260486610513 | NHAC 3.0T GE P 16 | LMT Medical Systems GmbH | 2021-10-27 |
| 04260486610469 | NHAC 1.5T GE P 16 | LMT Medical Systems GmbH | 2021-10-27 |
| 00195278124609 | NA | GE HEALTHCARE(TIANJIN) COMPANY LIMITED | 2021-02-02 |
| 04260486610629 | NBAC 1.5T SMS, Spine | LMT Medical Systems GmbH | 2020-08-23 |
| 04260486610230 | NBAC 1.5T SMS, Flex | LMT Medical Systems GmbH | 2020-08-23 |
| 04260486610438 | NHAC 1.5T SMS 16 | LMT Medical Systems GmbH | 2020-08-23 |
| 04260486610445 | NHAC 3.0T SMS 16 | LMT Medical Systems GmbH | 2018-03-15 |
| 04260486610216 | NBAC 3.0T SMS, Flex | LMT Medical Systems GmbH | 2018-03-14 |
| 04260486610209 | NBAC 3.0T SMS, Spine | LMT Medical Systems GmbH | 2018-03-14 |
| 08056304450029 | G-scan Brio | ESAOTE SPA | 2016-09-27 |
| 08056304451095 | S-scan | ESAOTE SPA | 2016-09-27 |
| 08165890202018 | AtamA™ System | MONTERIS MEDICAL INC | 2016-09-02 |
| 04987670101359 | 4ch Flex SPEEDER | CANON INC. | 2016-09-01 |