Bioimaging and radiotherapy instrumentsMagnetic resonance imaging (MRI) instrumentsMagnetic resonance (mr) systems
Closed magnet MRI scanners with magnetic field less than or equal to 2t
EMDN code Z11050104
Manufacturers registered in Europe (EUDAMED) 17
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| GE Healthcare FDA EU representative : GE Medical Systems SCS (France) | China | IIa MDR | eudamed@gehealthcare.com EUDAMED record Report an error | |
| Shanghai United Imaging Healthcare FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIa MDR | services@united-imaging.com EUDAMED record Report an error | |
| Alltechmed FDA EU representative : Caretechion GmbH (Germany) | China |
|
IIa 93/42 | sales@alltechmed.com EUDAMED record Report an error |
| Beijing Wandong Medical Technology FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China | IIa MDR | EUDAMED record Report an error | |
| Fujifilm FDA EU representative : FUJIFILM Healthcare Europe GmbH (Germany) | Japan | IIa MDR | EUDAMED record Report an error | |
| Kuanteng (Liaoning) Medical Devices EU representative : Lotus NL B.V. (Netherlands) | China |
|
IIa 93/42 | EUDAMED record Report an error |
| Philips FDA | Netherlands |
|
IIb MDR | eudamed@philips.com EUDAMED record Report an error |
| Siemens Shenzhen Magnetic Resonance FDA EU representative : Siemens Healthcare GmbH (Germany) | China | IIa MDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Anke EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
IIa 93/42 | EUDAMED record Report an error |
| Canon FDA EU representative : Canon Medical Systems Europe B.V. (Netherlands) | Japan |
|
IIa MDR | eudamed-info@mail.canon EUDAMED record Report an error |
| GE Medical Systems FDA EU representative : GE Medical Systems SCS (France) | United States | IIa MDR | eudamed@gehealthcare.com EUDAMED record Report an error | |
| Hyperfine FDA EU representative : Emergo Europe B.V. (Netherlands) | United States | IIa MDR | Website eudamed@hyperfine.io EUDAMED record Report an error | |
| Neoscan Solutions FDA | Germany | IIa MDR | Website info@neoscan-solutions.com EUDAMED record Report an error | |
| Neusoftmedical FDA EU representative : Emergo Europe B.V. (Netherlands) | China | IIa MDR | EUDAMED record Report an error | |
| Shenzhen Basda Medical Apparatus EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) | China |
|
IIa 93/42 | EUDAMED record Report an error |
| Siemens Healthcare FDA | Germany | IIa MDR | Website contact@siemens-healthineers.com EUDAMED record Report an error | |
| Siemens Healthineers FDA | Germany | IIa MDR | Website contact@siemens-healthineers.com EUDAMED record Report an error |
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) 26
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 |
|---|---|---|---|
| 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 | registered |
| Usa Instruments, Inc. | United States | – | registered |
| BrainSpec Inc. | United States | BrainSpec Core™ Software | registered |
| 20MED PTE LTD | Singapore | – | registered |
| AGITO Medical A/S | Denmark | – | registered |
| Block Imaging SAS | United States | – | registered |
| Can Technomed Trading LTD. | Canada | – | registered |
| DHL Supply Chain (Netherlands) B.V. | Netherlands | – | registered |
| Elsmed Ltd. | Israel | – | registered |
| Everx Japan Co. Ltd | Japan | – | registered |
| FUJITA CO., LTD. | Japan | – | registered |
| HM Product Solutions, Ltd. | United States | – | registered |
| LBN Medical ApS | Denmark | – | registered |
| LJ Business Corporation | Japan | – | registered |
| M-solutions Inc. | Japan | – | registered |
| Medical Resale PTY Limited | Australia | – | registered |
| Medivest Group | United Kingdom | – | registered |
| Nova Medical, Inc Present in Europe in other categories | United States | – | registered |
| PROBO Medical SAS | France | – | registered |
| Quality Electrodynamics, LLC Present in Europe in other categories | United States | – | registered |
| Rapid Biomedical GmbH Present in Europe in other categories | Germany | – | registered |
| SUMITOMO MITSUI FINANCE AND LEASING CO., LTD. | Japan | – | registered |
| Scandinavian Medical Solutions A/S | Denmark | – | registered |
| Siaron Medical Ltd | Canada | – | registered |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | – | K962627 (1997) |
| U.S. Imaging, Inc. Present in Europe in other categories | United States | – | registered |
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