Radiochemical Co.
CanadaFDA applicant, unverified
- Devices
- 1
What Radiochemical Co. makes
Radiochemical Co. manufactures the SELECTRON LDR, a low-dose-rate (LDR) brachytherapy device used for targeted radiation treatment in oncology, typically for prostate, cervical, or breast cancer.
The SELECTRON LDR is classified as a Class II medical device in the US and is authorised via the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Selectron Ldr Selectron Low Dose Rate Ref K844714
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Radiochemical Co. have in the registry?
The registry currently lists 1 device for Radiochemical Co.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Radiochemical Co.'s devices?
Among its 1 most recently registered device, Radiochemical Co. has devices listed in FDA 510(k) (1 device).
What risk classes do Radiochemical Co.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Radiochemical Co.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Radiochemical Co. in the registry?
The most recently registered devices listed for Radiochemical Co. include SELECTRON LDR SELECTRON LOW DOSE RATE.