Bioimaging and radiotherapy instrumentsDiagnostic and interventional radiology instrumentsVarious instruments for radiodiagnostics and interventional procedures
Mobile radioscopic units
EMDN code Z11039017
Manufacturers registered in Europe (EUDAMED) 24
- 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) 47
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 |
|---|---|---|---|
| Medtronic Navigation, Inc. Present in Europe in other categories | United States | O-ARM® O-arm O-arm O2 O-armTM O2 Imaging System | registered |
| OXOS Medical, Inc. | United States | MC2 Portable X-ray System Cart MC2 App Emitter Foot Pedal Cassette | registered |
| Ziehm-Orthoscan, Inc. Present in Europe in other categories | United States | OrthoScan Mobile DI Mini C-arm OrthoScan Pulse Mini C-arm Orthoscan TAU MVP 1515 TAU Model 1000-0016 Mini C-Arm Orthoscan TAU MVP 2020 Orthoscan Versa Mini C-Arm | K252579 (2026) |
| GE Medical Systems Present in Europe in other categories | United States | Allia IGS WF BP | K980322 (1998) |
| Genoray Co., Ltd. Present in Europe in other categories | South Korea | Genoray | registered |
| GEMSS MEDICAL SYSTEMS CO.,LTD. | United States | IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYSTEM, MOBILE SYSTEM, X-RAY, FLUOROSCOPIC, IMAGE-INTENSIFIED Interventional Fluoroscopic Mobile X-ray System | K160065 (2016) |
| OEC MEDICAL SYSTEMS, INC. | United States | OEC | registered |
| Beijing East Whale Imaging Technology Co., Ltd. | China | WHALE | K163429 (2017) |
| TURNER IMAGING SYSTEMS Present in Europe in other categories | United States | Smart-C | K190024 (2019) |
| Ecential Robotics Present in Europe in other categories | France | Broach Set SPX1 3D Imaging Set SPX1 | registered |
| Globus Medical, Inc. Present in Europe in other categories | United States | EXCELSIUS3D | registered |
| Hologic, Inc. Present in Europe in other categories | United States | Flourocsan InSight | K120388 (2012) |
| NVIEW MEDICAL INC. | United States | nView s1 with nav option | registered |
| ANDA Medical | Canada | – | registered |
| Aspen Imaging Healthcare, Inc. | United States | – | registered |
| Block Imaging SAS | United States | – | registered |
| Can Technomed Trading LTD. | Canada | – | registered |
| Canadian Imaging Services Inc. | Canada | – | registered |
| EverX / Bindra | Australia | – | registered |
| FLEXRAY MEDICAL | Denmark | – | 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 |
| Ge Hangwei Medical Systems Co., Ltd. Present in Europe in other categories | China | – | K160131 (2016) |
| Ge Oec Medical Systems, Inc. | United States | – | K233669 (2024) |
| Hefei Chimed Intelligent Machine Co., Ltd. | China | – | K251004 (2025) |
| Imaging Engineering, LLC | United States | – | registered |
| LBN Medical ApS | Denmark | – | registered |
| LJ Business Corporation | Japan | – | registered |
| MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI | Türkiye | – | registered |
| MULTISOURCE MANUFACTURING LLC | United States | – | registered |
| Makar Consulting Pty Ltd | Australia | – | registered |
| Medical Resale PTY Limited | Australia | – | registered |
| Medivest Group | United Kingdom | – | registered |
| Medtronic, Inc. Present in Europe in other categories | United States | – | registered |
| Orthoscan, Inc. Present in Europe in other categories | United States | – | K213113 (2021) |
| PROBO Medical SAS | France | – | registered |
| QUALITY TECH SERVICES, LLC | United States | – | registered |
| SIMAGEC | France | – | registered |
| SUMITOMO MITSUI FINANCE AND LEASING CO., LTD. | Japan | – | registered |
| Sanmina Corporation | United States | – | registered |
| Scandinavian Medical Solutions A/S | Denmark | – | registered |
| Sedecal., Sa. Present in Europe in other categories | United States | – | registered |
| Shimadzu Corp. Present in Europe in other categories | United States | – | K043379 (2005) |
| Siemens Healthineers AG Present in Europe in other categories | Germany | – | registered |
| Siemens Medical Solutions USA, Inc. Present in Europe in other categories | United States | – | K051133 (2005) |
| XORAN TECHNOLOGIES LLC Present in Europe in other categories | United States | – | registered |
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