Medical Device Manufacturer · US , Salt Lake City , UT

Ge Dec Medical Systems - FDA 510(k) Cleared Devices

10 submissions · 10 cleared · Since 1994

Recent clearances: INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS), SERIES 7600 MOBILE DIGITAL C-ARM

10

Total

10

Cleared

0

Denied

FDA 510(k) Regulatory Record - Ge Dec Medical Systems Radiology ✕

10 devices

1-10 of 10

Cleared Apr 11, 2000

SERIES 7700 MOBILE C-ARM, COMPACT 7700 MOBILE C-ARM, COMPACT 7700 PLUS MOBILE...

Radiology · 78d

Cleared Dec 21, 1999

Radiology · 50d

Cleared Aug 19, 1999

MINI 6800 DIGITAL MOBILE C-ARM

Radiology · 23d

Cleared Feb 17, 1998

INTERVENTIONAL MOBILE DIGITAL IMAGING SYSTEM (HEREIN CALLED IMDIS)

Radiology · 90d

Cleared Mar 11, 1997

SERIES 7600 MOBILE DIGITAL C-ARM

Radiology · 63d

Cleared Dec 23, 1996

SERIES 9600 MOBILE DIGITAL IMAGING SYSTEM

Radiology · 82d

Cleared Jun 05, 1995

Radiology · 104d

Cleared May 11, 1995

SERIES 6600 DIGITAL MOBILE C-ARM

Radiology · 24d

Cleared Aug 22, 1994

UROVIEW MODEL 2600

Radiology · 213d

Cleared Jan 25, 1994

UROVIEW SYSTEMS TOMOGRAPHY OPTION SOFTWARE

Radiology · 34d