Indiana University Cyclotron Facility
Country not established
- Devices
- 1
What Indiana University Cyclotron Facility makes
The Indiana University Cyclotron Facility manufactures proton therapy systems designed for precise radiation treatment in oncology, delivering high-energy proton beams to target tumors with reduced exposure to surrounding healthy tissue.
These systems are classified as Class II medical devices under US regulations and are listed via the FDA’s 510(k) pathway. The facility operates from the United States.
Catalogue
Proton Therapy System Ref K062891
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Indiana University Cyclotron Facility have in the registry?
The registry currently lists 1 device for Indiana University Cyclotron Facility. Devices recorded under merged duplicate company entries are counted once.
Which registries list Indiana University Cyclotron Facility's devices?
Among its 1 most recently registered device, Indiana University Cyclotron Facility has devices listed in FDA 510(k) (1 device).
What risk classes do Indiana University Cyclotron Facility's devices fall under?
Among its 1 most recently registered device, the classes recorded for Indiana University Cyclotron Facility's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Indiana University Cyclotron Facility in the registry?
The most recently registered devices listed for Indiana University Cyclotron Facility include PROTON THERAPY SYSTEM.