Proxima Therapeutics, Inc.
United StatesFDA applicant, unverified
- Devices
- 5
What Proxima Therapeutics, Inc. makes
Proxima Therapeutics manufactures high-dose-rate (HDR) brachytherapy accessories and trays for radiation therapy systems, including the Mammosite RTS and GliaSite RTS. These products support afterloading devices used in targeted breast and brain tumor treatments, delivering precise radiation doses.
The company’s devices are classified as Class II under FDA regulations and are recorded in the 510(k) premarket notification database. The portfolio is listed in the US, where the manufacturer is based.
Catalogue
Mammosite Ii Radiation Therapy System (Rts) Tray, Mammosite Hdr Afterloader Accessories Tray Ref K041929
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Mammosite Radiation Therapy System (Rts) Tray, Mammosite Hdr Afterloader Accessories Tray Ref K030558
Regimes: 510(k) Registry: 510(k)Mammosite Radiation Therapy System (Rts) Tray, Mammosite Hdr Afterloader Accessories Tray Ref K011690
Regimes: 510(k) Registry: 510(k)Mammosite Radiation Therapy System (Rts) Tray, Mammosite Hdr Afterloader Accessories Tray Ref K032067
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Proxima Therapeutics, Inc. have in the registry?
The registry currently lists 5 devices for Proxima Therapeutics, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Proxima Therapeutics, Inc.'s devices?
Among its 5 most recently registered devices, Proxima Therapeutics, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Proxima Therapeutics, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Proxima Therapeutics, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Proxima Therapeutics, Inc. in the registry?
The most recently registered devices listed for Proxima Therapeutics, Inc. include MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY, GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020, 1030, 1040, 8150, 9005 and MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER ACCESSORIES TRAY.