American Radiosurgery, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What American Radiosurgery, Inc. makes
American Radiosurgery, Inc. manufactures radiosurgery systems, including the Gamma ART-6000 rotating gamma knife for precise stereotactic radiation therapy, and treatment planning software like the Explorer 4D system for radiation dose calculation and patient positioning.
The company’s devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The portfolio is listed in the FDA’s 510(k) registry, and the manufacturer is based in the United States.
Catalogue
Rotating Gamma System. Gamma Art-6000 Ref K060314
Regimes: 510(k) Registry: 510(k)Explorer 4D Treatment Planning System Ref K101220
Regimes: 510(k) Registry: 510(k)Explorer 4D Treatment Planning System Ref K093588
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does American Radiosurgery, Inc. have in the registry?
The registry currently lists 3 devices for American Radiosurgery, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list American Radiosurgery, Inc.'s devices?
Among its 3 most recently registered devices, American Radiosurgery, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do American Radiosurgery, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for American Radiosurgery, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from American Radiosurgery, Inc. in the registry?
The most recently registered devices listed for American Radiosurgery, Inc. include ROTATING GAMMA SYSTEM. GAMMA ART-6000 and EXPLORER 4D TREATMENT PLANNING SYSTEM.