Infra Vision Imaging System

• • Terminated Z-0906-2011 FDA Unclassified (pre-2012) ·initiated 29 Sep 2010 ·on shared 510(k) K945297

  Product may not adequately visualize IR light emitted from U- and E- kits due to a manufacturing error.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K945297 ↗

FDA Product Code

GCJ

Device Class

Class II

Regulation

21 CFR Part 876.1500

Advisory Committee

Gastroenterology, Urology

FDA Decision

SESE Substantially Equivalent

• Gabriel Ureteral Illuminator System

  Class II

  FDA 510(k) K940019 Active Cleared 2 May 1994

• Gabriel Ureteral Illuminator System II

  Class II

  FDA 510(k) K945088 Active Cleared 7 Feb 1995

• Infra Vision Bougie Kit, Infra Vision Esophageal Kit

  Class II

  FDA 510(k) K960173 Active Cleared 27 Jun 1996

• Gabriel Medical Cls Thermal Recorder

  Class I

  FDA 510(k) K901385 Active Cleared 9 May 1990