Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsRadiology instruments
Radiology instruments - hardware accessories
EMDN code Z11030580
Manufacturers registered in Europe (EUDAMED) 12
- 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) 10
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 |
|---|---|---|---|
| HUESTIS MACHINE CORPORATION | United States | Huestis Medical Collimator Huestis Medical Collilmator | registered |
| COLLIMARE, LLC | United States | Collimare | registered |
| Carestream Health, Inc. Present in Europe in other categories | United States | LINEAR MC 150 | registered |
| Iray Imaging Technology (Haining) Limited | China | iRay | registered |
| RALCO SRL | United States | Ralco srl | K110856 (2011) |
| DRGEM Corporation Present in Europe in other categories | South Korea | DRGEM | registered |
| Varex Imaging Corporation Present in Europe in other categories | United States | Varex Imaging | registered |
| DENTSPLY SIRONA INC | United States | – | registered |
| Fairy Medical Electrics(Jiaxing)Co.,LTD | China | – | registered |
| Philips Medical Systems Nederland B.V. Present in Europe in other categories | Netherlands | – | registered |
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