FDA Product Code FET: Endoscopic Video Imaging System/component, Gastroenterology-urology
FDA product code FET covers endoscopic video imaging systems and components for gastrointestinal endoscopy.
These systems integrate a high-definition camera, light source, and image processing unit to display real-time video images of the gastrointestinal tract during endoscopy. Advanced systems include narrow-band imaging, chromoendoscopy, and AI-assisted polyp detection capabilities.
FET devices are Class II medical devices, regulated under 21 CFR 876.1500 and reviewed by the FDA Gastroenterology & Urology panel.
Leading manufacturers include KARL STORZ Endoscopy-America, Inc., Olympus Medical Systems Corporation and Olympus Medical Systems Corp..
100
Total
100
Cleared
106d
Avg days
1981
Since
100 devices
Cleared
Feb 07, 1994
EPM-3300 VIDEO PROCESSOR
Pentax Precision Instrument Corp.
Gastroenterology & Urology
115d
Cleared
Aug 14, 1991
COLOR VIDEO CAMERA
United States Endoscopy Group, Inc.
Gastroenterology & Urology
132d
Cleared
Apr 17, 1987
OPTICAL CONSOLE(TM) AND OPTICAL CATHETER(TM)
Medline Industries, Inc.
Gastroenterology & Urology
57d
Cleared
Jan 21, 1986
OLYMPUS EVS-ENDOSCOPIC VIDEO IMAGE & DATA SYS
Olympus Corp.
Gastroenterology & Urology
148d
Cleared
Oct 04, 1984
VIDEO URODYNAMICS SYS 1906B-Y & 1906C-Y
Life-Tech Intl., Inc.
Gastroenterology & Urology
51d