Medical Device Manufacturer · US , Alpharetta , GA

Proxima Therapeutics, Inc. - FDA 510(k) Cleared Devices

5 submissions · 4 cleared · Since 2001

5

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Proxima Therapeutics, Inc. Radiology ✕

5 devices

1-5 of 5

Cleared Aug 26, 2004

MAMMOSITE II RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...

Radiology · 38d

Cleared Feb 10, 2004

MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...

Radiology · 222d

Cleared May 21, 2003

MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...

Radiology · 89d

Cleared May 06, 2002

MAMMOSITE RADIATION THERAPY SYSTEM (RTS) TRAY, MAMMOSITE HDR AFTERLOADER...

Radiology · 340d

Cleared Apr 25, 2001

GLIASITE RADIATION THERAPY SYSTEM (RTS), MODEL 1020,1030,1040,8150,9005

Radiology · 194d