Helax AB
Country not established
- Devices
- 3
What Helax AB makes
Helax AB manufactures radiation therapy treatment planning systems, including the HELAX-VISIR for visualization and the HELAX-TMS V 5.0 for treatment planning. The company also produces the HELAX-IMCON, Version 1.0, a software tool for imaging and contouring in radiotherapy workflows.
These devices are classified as Class II under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States.
Catalogue
Helax-Visir Ref K972617
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Helax-Imcon, Version 1.0 Ref K982857
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Helax AB have in the registry?
The registry currently lists 3 devices for Helax AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Helax AB's devices?
Among its 3 most recently registered devices, Helax AB has devices listed in FDA 510(k) (3 devices).
What risk classes do Helax AB's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Helax AB's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Helax AB in the registry?
The most recently registered devices listed for Helax AB include HELAX-VISIR, HELAX-TMS V 5.0 RADIATION THERAPY TREATMENT PLANNING SYSTEM and HELAX-IMCON, VERSION 1.0.