Magnetic resonance imaging (MRI) instrumentsMagnetic resonance (mr) systemsMagnetic resonance (mr) systems - hardware accessories
Magnetic resonance (mr) radiofrequency surface coils
EMDN code Z1105018001
Manufacturers registered in Europe (EUDAMED) 8
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 62
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Noras Mri Products GmbH Present in Europe in other categories | Germany | Breast BI 7 MR Coil Set 3T NORAS OR HEADCOIL Top Array Siemens 1.5T Refurbished NORAS OR HEAD COIL Bottom Array Siemens 1.5T NORAS OR HEADCOIL Bottom Array Siemens 1.5T Refurbished NORAS OR HEAD COIL Top Array Philips 3T NORAS OR HEAD COIL Top Array Siemens 1.5T | K241069 (2024) |
| Siemens Healthcare GmbH Present in Europe in other categories | Germany | MAGNETOM Avanto MAGNETOM Flow.Elite MAGNETOM Flow.Neo Flex Large 4 MR coil 3T MAGNETOM Prisma MAGNETOM Sola | registered |
| Siemens Shenzhen Magnetic Resonance Ltd. Present in Europe in other categories | China | MAGNETOM ESSENZA MAGNETOM Spectra MAGNETOM Amira MAGNETOM Sempra MAGNETOM Free.Star MAGNETOM Flow.Plus | registered |
| Usa Instruments, Inc. | United States | 1.5T AIR Posterior Array | K052916 (2005) |
| SCANMED, LLC Present in Europe in other categories | United States | ScanMed PROCURE™ Coil ScanMed Knee/Foot Coil ScanMed Elbow Coil ScanMed Blanket Coil ScanMed Shoulder/Knee (M) Coil ScanMed Long Bone (L) Coil | registered |
| Rapid Biomedical GmbH Present in Europe in other categories | Germany | 13C/1H Head Coil 23Na/1H Head Coil 31P/1H Head Coil 1.5T Endorectal Coil 16Ch Diagnostic Breast Coil 31P/1H TxRx Flex Loop 7T | K213480 (2023) |
| IMRIS Imaging, Inc. Present in Europe in other categories | United States | InSitu Coil HC300 -3T Head Coil Lower Assy HC300- 3T Head Coil Upper Assy HC150 - 1.5T Head Coil Upper Assy HC150 - 1.5T Head Coil Lower HC150 - 1.5T Head Coil Lower Assy | registered |
| Mr Instruments, Inc. | United States | DuoFLEX® Coil Suite 32Ch Head Coil 1.5T DuoFLEX Standard Suite | K173290 (2017) |
| Shenzhen RF Tech Co., Ltd. Present in Europe in other categories | China | RFT | K252587 (2026) |
| DXTX MEDICAL INC Present in Europe in other categories | United States | DxTx Medical 1.5T eCoil Imaging Device FRU (for Philips Ingenia) DxTx Medical 1.5T eCoil Imaging Device (for GE) 3.0T Ingenia Endorectal Coil Interface Device (eCoil®) DxTx Medical 3T eCoil Imaging Device (for Siemens) DxTx Medical 1.5T eCoil Imaging System Disposables (Prostate - Philips) 1.5T Ingenia Endorectal Coil Interface Device (eCoil®) | K243428 (2025) |
| Monteris Medical, | United States | AtamA™ System AtamA System | K132444 (2014) |
| Bayer Medical Care Inc. Present in Europe in other categories | United States | MEDRAD® eCoil Imaging System (for Philips Ingenia) MEDRAD® 3.0T eCoil Imaging System (for Philips) MEDRAD® 3.0T eCoil Imaging System (for GE) MEDRAD® 1.5T eCoil Interface Device (for Philips) MEDRAD® 3.0T eCoil Imaging System (for Siemens) MEDRAD® 1.5T eCoil Imaging System (for Philips) | registered |
| Siemens Healthineers AG Present in Europe in other categories | Germany | MAGNETOM Altea MAGNETOM Vida MAGNETOM Lumina MAGNETOM Sola BIOGRAPH One MAGNETOM Viato.Mobile | registered |
| Inkspace Imaging, Inc. | United States | Snuggle Pediatric Array InkSpace Imaging Body Array Snuggle Pediatric Array – PH 3T (Dino) Nuzzle Body Array – PH 3T (Whimsical) Silhouette Adult Array Snuggle Pediatric Array, 1.5T | K262813 (2026) |
| Machnet BV | United States | – | K013985 (2002) |
| Canon, Inc. Present in Europe in other categories | United States | 4ch Flex SPEEDER Octave SPEEDER Head QD KNEE/FOOT COIL Atlas Speeder Coil Octave SPEEDER Spine | registered |
| Nova Medical, Inc Present in Europe in other categories | United States | 3T 32 CH Head Coil 2Tx32Rx 7T Head Coil 8Tx32Rx 7T Head Coil 1Tx32Rx 7T Head Coil | K182737 (2019) |
| Hyperfine Operations, Inc. | – | Swoop Transmit and Receive Radio Frequency Head Coil | registered |
| Promaxo, Inc. | United States | Promaxo MRI System MRI Medium RX Coil (Receive Only) Template Holder with Fiducials | registered |
| Polarean, Inc. | United States | XENOVIEW 3.0T Chest Coil XENOVIEW 3.0T Chest Coil-GE Premier | K243316 (2024) |
| Shanghai United Imaging Healthcare Co., Ltd. Present in Europe in other categories | China | uMR | K183186 (2019) |
| ClearPoint Neuro, Inc. Present in Europe in other categories | United States | ClearPoint | registered |
| MEDSPIRA, LLC | United States | 3.0T BC-10 Transmit/Receive MRI Coil 1.5T BC-10 Transmit/Receive MRI Coil | registered |
| Aspect Imaging, Ltd. | Israel | Embrace Neonatal MRI System | registered |
| TIME MEDICAL SYSTEMS Present in Europe in other categories | China | PICA Whole-body MRI System | K112293 (2011) |
| 20MED PTE LTD | Singapore | – | registered |
| AGITO Medical A/S | Denmark | – | registered |
| Avnet, Inc. | United States | – | registered |
| BENCHMARK ELECTRONICS, INC. | United States | – | registered |
| Block Imaging SAS | United States | – | registered |
| Can Technomed Trading LTD. | Canada | – | registered |
| Creative Foam Corporation | United States | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| DirectMed Imaging, LLC | United States | – | registered |
| EVOLVE MANUFACTURING TECHNOLOGIES INC. | United States | – | registered |
| Everx Japan Co. Ltd | Japan | – | registered |
| FUJITA CO., LTD. | Japan | – | registered |
| Fujifilm Corporation Present in Europe in other categories | Japan | – | registered |
| HM Product Solutions, Ltd. | United States | – | registered |
| Haywood Vocational Opportunities | United States | – | registered |
| Hitachi Medical Systems America, Inc. Present in Europe in other categories | United States | – | K162079 (2016) |
| Hyperfine, Inc. Present in Europe in other categories | United States | – | registered |
| Insight Medbotics, Inc. | Canada | – | K223484 (2023) |
| Invivo Corporation Present in Europe in other categories | United States | – | K213766 (2021) |
| Invivo Corporation (Business Trade Name: Philips) Present in Europe in other categories | United States | – | K232762 (2023) |
| Invivo Therapeutics Corporation | United States | – | K162863 (2016) |
| Kuehne GmbH | Germany | – | registered |
| LBN Medical ApS | Denmark | – | registered |
| LJ Business Corporation | Japan | – | registered |
| M-solutions Inc. | Japan | – | registered |
| Makar Consulting Pty Ltd | Australia | – | registered |
| Medivest Group | United Kingdom | – | registered |
| Moras Mri Products GmbH | Germany | – | K162651 (2017) |
| PROBO Medical SAS | France | – | registered |
| Philips Medical System Nederlands B.V. | Netherlands | – | K233348 (2023) |
| Qfix Present in Europe in other categories | United States | – | K190668 (2019) |
| Scandinavian Medical Solutions A/S | Denmark | – | registered |
| Shanghai Chenshi Medical Instruments Co., Ltd | China | – | registered |
| Siaron Medical Ltd | Canada | – | registered |
| SteriPack USA (Limited) LLC | United States | – | registered |
| U.S. Imaging, Inc. Present in Europe in other categories | United States | – | registered |
| UIH TECHNOLOGIES LLC | United States | – | registered |
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