Bioimaging and radiotherapy instrumentsRadiotherapy and radiosurgery instrumentsRadiosurgery instruments
Radiosurgery instruments - software accessories
EMDN code Z11010782
Manufacturers registered in Europe (EUDAMED) 1
- 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 |
|---|---|---|---|---|
| Elekta FDA | Sweden |
|
IIb MDR | 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) 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 |
|---|---|---|---|
| Xcision Medical Systems, LLC | United States | GammaPod™ Breast Immobilization and Localization System GammaPod™ GammaPod™ Imager Loader and Couch GammaPod™ Treatment Control System GammaPod™ Treatment Planning System | K180571 (2018) |
| Elekta Instrument AB | Sweden | Leksell Gamma Knife Perfexion/Icon Leksell Gamma Knife Icon Leksell GammaPlan Leksell Gamma Knife C 4 4C Leksell Gamma Knife Perfexion Leksell Stereotactic System | K173789 (2018) |
| Sun Nuclear Corp. Present in Europe in other categories | United States | ISORAD Detector, 1-4MV (+) 3m ISORAD Detector, 6-12MV (-) 1.5m ISORAD Detector, 6-12MV (-) 3m ISORAD Detector, 6-12MV (+) 3m ISORAD Detector, 1-4MV (-) 3m ISORAD Detector, 15-25MV (-) 1.5m | registered |
| Best Theratronics Ltd | Canada | GammaBeam Theratron | K150191 (2015) |
| Our Smd Medical (Wuhan) Co., Ltd. | China | SMD-XGD/AR Galaxy SMD Galaxy RTx | registered |
| Akesis, Inc. | United States | Galaxy RTi | K203146 (2021) |
| Our United Corporation | China | CybeRay | K203250 (2021) |
| BEST MEDICAL INTERNA | United States | – | registered |
| Masep Medical Science & Tech.Development (Shenzhen | United States | – | K102533 (2011) |
| Prowess, Inc. | United States | – | registered |
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