Medical Device Manufacturer · US , Brookline , MA

Radionics Software Applications, Inc. - FDA 510(k) Cleared Devices

12 submissions · 12 cleared · Since 1993

12

Total

12

Cleared

0

Denied

FDA 510(k) Regulatory Record - Radionics Software Applications, Inc. Radiology ✕

6 devices

1-6 of 6

Cleared Oct 28, 1997

Radiology · 83d

Cleared Aug 22, 1996

GILL-THOMAS-COSMAN(GTC) DENTAL TRAY

Radiology · 79d

Cleared Apr 17, 1996

Radiology · 103d

Cleared Nov 13, 1995

OPERATING ARM SYSTEM (OAS)

Radiology · 237d

Cleared Oct 25, 1995

Radiology · 93d

Cleared Aug 18, 1993

LINAC-BASED STEROTACTIC RADIOSURGERY

Radiology · 398d