Radiadyne
Country not established
- Devices
- 5
What Radiadyne makes
Radiadyne manufactures medical devices used in radiation therapy and prostate procedures, including rectal and vaginal balloon systems for patient immobilization and positioning. Their products also include systems designed to track and monitor joint motion, such as the OARTRAC System, which aids in precise anatomical alignment during treatment.
The company’s devices are classified under FDA Class II regulations and are listed via the 510(k) clearance process. These products are intended for use in the United States, where they are subject to compliance with the FDA’s medical device regulations.
Catalogue
Prostate Immobilizer Rectal Balloon Ref DEN130036
Regimes: De Novo Registry: De NovoAlatus Vaginal Balloon Packing System Ref K092534
Regimes: 510(k) Registry: 510(k)OARtrac System with Skin Sensors Ref K150719
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Oartrac System Ref K141154
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Radiadyne have in the registry?
The registry currently lists 5 devices for Radiadyne. Devices recorded under merged duplicate company entries are counted once.
Which registries list Radiadyne's devices?
Among its 5 most recently registered devices, Radiadyne has devices listed in FDA 510(k) (5 devices).
What risk classes do Radiadyne's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Radiadyne's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Radiadyne in the registry?
The most recently registered devices listed for Radiadyne include PROSTATE IMMOBILIZER RECTAL BALLOON, ALATUS VAGINAL BALLOON PACKING SYSTEM, OARtrac System with Skin Sensors and OARtrac System with Patient Specific Reusable Universal PSD Sensors.