Gammamed USA
Country not established
- Devices
- 1
What Gammamed USA makes
Gammamed USA manufactures the GammaMed Plus High Dose Rate Remote Afterloading System, a device designed for precise radiation therapy delivery in clinical settings. This system is used for brachytherapy procedures, allowing controlled administration of radioactive sources to target tissues while minimizing exposure to medical staff.
The company’s portfolio is regulated under Class II medical devices in the United States, with the GammaMed Plus system authorised via the FDA’s 510(k) clearance process. The manufacturer operates from the US, adhering to domestic regulatory requirements for radiation therapy equipment.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gammamed USA have in the registry?
The registry currently lists 1 device for Gammamed USA. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gammamed USA's devices?
Among its 1 most recently registered device, Gammamed USA has devices listed in FDA 510(k) (1 device).
What risk classes do Gammamed USA's devices fall under?
Among its 1 most recently registered device, the classes recorded for Gammamed USA's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gammamed USA in the registry?
The most recently registered devices listed for Gammamed USA include GAMMAMED PLUS HIGH DOSE RATE REMOTE AFTERLOADING SYSTEM.