Medical Device Manufacturer · US , Sanford , FL

Omega Medical Imaging, Inc. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 1990

8

Total

8

Cleared

0

Denied

FDA 510(k) Regulatory Record - Omega Medical Imaging, Inc. Radiology ✕

8 devices

1-8 of 8

Cleared Aug 31, 2010

Radiology · 230d

Cleared Feb 03, 2010

R650 QDASM COLLIMATOR

Radiology · 77d

Cleared May 18, 2007

CS-SERIES FLUOROSCOPY SYSTEM, CS-10 THROUGH CS-65 (11 CONFIGURATIONS)

Radiology · 52d

Cleared Oct 20, 2006

E-VIEW FLUOROSCOPY SYSTEM, MODEL CS-50

Radiology · 44d

Cleared Jan 31, 2005

R605 FACS COLLIMETER

Radiology · 17d

Cleared Feb 02, 1999

B-400 CEILING MOUNTED POSSITIONER, MODEL B-400

Radiology · 26d

Cleared May 14, 1997

B-350 CEILING MOUNTED C-POSITIONER

Radiology · 61d

Cleared Sep 20, 1990

MODEL B-200 C-ARM & MODEL C-300 CARDIAC TABLE

Radiology · 139d