Bioimaging and radiotherapy instrumentsMagnetic resonance imaging (MRI) instruments
Magnetic resonance (mr) systems
EMDN code Z110501
Manufacturers registered in Europe (EUDAMED) 25
- 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) 66
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) |
| 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 | InVision 1.5 Surgical Theatre InVision™ 1.5T Operating Suite InVision™ 3T Operating Suite InVision™ 3T Recharge Operating Suite IMRIS iMRI 3T V InSitu Coil | 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) |
| 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 |
| 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) |
| 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) |
| BrainSpec Inc. | United States | BrainSpec Core™ Software | registered |
| 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 |
| 20MED PTE LTD | Singapore | – | registered |
| AGITO Medical A/S | Denmark | – | registered |
| Anzai Medical Co., Ltd. | Japan | – | registered |
| Avnet, Inc. | United States | – | registered |
| BENCHMARK ELECTRONICS, INC. | United States | – | registered |
| Block Imaging SAS | United States | – | registered |
| Cablon Medical B.V. Present in Europe in other categories | Netherlands | – | 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 |
| Elsmed Ltd. | Israel | – | registered |
| Everx Japan Co. Ltd | Japan | – | registered |
| FUJITA CO., LTD. | Japan | – | registered |
| Greens Surgicals Private Limited | India | – | 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) |
| Hospital & Homecare Imp. & Exp. Co., Ltd | China | – | 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 |
| LifeSync Corporation | United States | – | registered |
| M-solutions Inc. | Japan | – | registered |
| MARKEN HEALTHTECH LIMITED | India | – | registered |
| Makar Consulting Pty Ltd | Australia | – | registered |
| Mark Enterprises | India | – | registered |
| Medical Resale PTY Limited | Australia | – | registered |
| Medivest Group | United Kingdom | – | registered |
| Moras Mri Products GmbH | Germany | – | K162651 (2017) |
| P BHOGILAL PVT LTD | India | – | registered |
| 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) |
| SUMITOMO MITSUI FINANCE AND LEASING CO., LTD. | Japan | – | registered |
| Scandinavian Medical Solutions A/S | Denmark | – | registered |
| Shanghai Chenshi Medical Instruments Co., Ltd | China | – | registered |
| Siaron Medical Ltd | Canada | – | registered |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | – | K962627 (1997) |
| 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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