Medical Device Manufacturer · US , Mchenry , IL

Gendex Corp. - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 1984

14

Total

14

Cleared

0

Denied

FDA 510(k) Regulatory Record - Gendex Corp. Radiology ✕

14 devices

1-14 of 14

Cleared Jun 29, 1995

GX-PAN PANORAMIC DENTAL X-RAY SYSTEM

Radiology · 23d

Cleared Feb 09, 1995

PROCESSOR, RADIOGRAPHIC-FILM, AUTOMATIC, DENTAL

Radiology · 80d

Cleared Feb 18, 1994

GX-770 X-RAY CONTROL, MODEL 46-404600G4

Radiology · 121d

Cleared Sep 29, 1993

VISUALIX RADIOGRAPHIC IMAGE DETECTING AND PROCESS

Radiology · 357d

Cleared Sep 14, 1993

Radiology · 200d

Cleared Jul 26, 1993

GXP DENTAL X-RAY PROCESSOR

Radiology · 54d

Cleared Jul 27, 1992

ATC725, ATC525, AND AP300

Radiology · 80d

Cleared Apr 28, 1992

GX-C CEPHALOMETER

Radiology · 104d

Cleared Oct 03, 1989

Radiology · 109d

Cleared Mar 31, 1989

GX-2000 STATIONARY X-RAY GENERATOR

Radiology · 80d

Cleared Oct 30, 1987

GX-MOBILE X-RAY UNIT

Radiology · 30d

Cleared Apr 22, 1986

GENDEX PRINCE 30 MEDICAL X-RAY GENERATOR

Radiology · 161d

Cleared Feb 12, 1986

TBX MEDICAL X-RAY TABLE

Radiology · 98d

Cleared Aug 02, 1984

Radiology · 41d