Scanditronix Wellhofer GmbH
GermanyFDA applicant, unverified
- Devices
- 1
What Scanditronix Wellhofer GmbH makes
Scanditronix Wellhofer GmbH manufactures the COMPASS, a medical device designed for intraoperative radiation therapy (IORT) planning and delivery, ensuring precise dose distribution during surgical procedures.
The COMPASS is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Compass Ref K072374
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Scanditronix Wellhofer GmbH have in the registry?
The registry currently lists 1 device for Scanditronix Wellhofer GmbH. Devices recorded under merged duplicate company entries are counted once.
Which registries list Scanditronix Wellhofer GmbH's devices?
Among its 1 most recently registered device, Scanditronix Wellhofer GmbH has devices listed in FDA 510(k) (1 device).
What risk classes do Scanditronix Wellhofer GmbH's devices fall under?
Among its 1 most recently registered device, the classes recorded for Scanditronix Wellhofer GmbH's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Scanditronix Wellhofer GmbH in the registry?
The most recently registered devices listed for Scanditronix Wellhofer GmbH include COMPASS.