Medical Device Manufacturer · US , Brookline , MA

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

12 submissions · 12 cleared · Since 1993

Recent clearances: XPLAN-1, OPTICAL TRACKING SYSTEM (OTS)

12

Total

12

Cleared

0

Denied

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

6 devices

1-6 of 6

Cleared Mar 04, 1999

OPTICAL TRACKING SYSTEM MICROSCOPE MODULE II, MODEL OTS MMII

Neurology · 30d

Cleared Apr 21, 1998

OPTICAL TRACKING SYSTEM (OTS)

Neurology · 133d

Cleared Jun 02, 1997

OPTICAL TRACKING SYSTEM (OTS)

Neurology · 185d

Cleared Oct 23, 1996

OPERATING ARM SYSTEM (OAS) [WITH CT AND MR IMAGES]

Neurology · 163d

Cleared Oct 26, 1995

Neurology · 409d

Cleared Mar 14, 1995

Neurology · 81d