Bioimaging and radiotherapy instrumentsVarious bioimaging and radiotherapy instruments
Bone densitometry systems
EMDN code Z119001
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) 20
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 |
|---|---|---|---|
| Mindways Software, Inc. Present in Europe in other categories | United States | QCT PRO Asynchronous 3D Spine and CTXA-Hip System QCT PRO Asynchronous 3D Spine Software QCT PRO 3D Volumetric Spine and CTXA Hip Software QCT PRO 3D Volumetric Spine Software CTXA Hip Extended Reference Data QCT PRO 3D Volumetric Spine System | K140342 (2014) |
| Medimaps Group SA Present in Europe in other categories | Switzerland | TBS iNsight Phantom | K243218 (2025) |
| Hologic, Inc. Present in Europe in other categories | United States | Horizon C Horizon W Horizon Wi Horizon A Horizon Ci | K130277 (2013) |
| 3D-Shaper Medical S.L Present in Europe in other categories | Spain | 3D-SHAPER | K251022 (2025) |
| O N DIAGNOSTICS LLC | United States | VirtuOst | K220402 (2023) |
| Block Imaging SAS | United States | – | registered |
| BunkerHill Health | United States | – | K242295 (2025) |
| Can Technomed Trading LTD. | Canada | – | registered |
| Curvebeam AI / Curvebeam, LLC | United States | – | K254072 (2026) |
| EverX / Bindra | Australia | – | registered |
| FUJITA CO., LTD. | Japan | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| GE HealthCare Technologies Inc. Present in Europe in other categories | United States | – | registered |
| General Commerce & Trade, S.A. de C.V. | Mexico | – | registered |
| HeartLung Corporation | United States | – | K213760 (2022) |
| LJ Business Corporation | Japan | – | registered |
| Makar Consulting Pty Ltd | Australia | – | registered |
| MedSource Parts, LLC | United States | – | registered |
| Medivest Group | United Kingdom | – | registered |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
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