Olympus Imagemanager System

• • Terminated Z-0047-04 FDA Unclassified (pre-2012) ·initiated 19 Aug 2003

  Software malfunction; potential for simultaneous cross-linking of exam images to another patient's file.

• • Terminated Z-1126-03 FDA Unclassified (pre-2012) ·initiated 5 Mar 2003

  Software defect; potential under certain circumstances to incorrectly identify endoscopy images that have been uploaded & saved to the network system.

510(k) Number

K934889 ↗

FDA Product Code

LMB

Device Class

Class I

Regulation

21 CFR Part 892.2010

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Olympus Direct Bilirubin Reagent

  Class II

  FDA 510(k) K924963 Active Cleared 30 Nov 1992

• Olympus Chloride Reagent, Modification

  Class II

  FDA 510(k) K934136 Active Cleared 5 Nov 1993

• Resectoscope Sheath

  Class II

  FDA 510(k) K931994 Active Cleared 17 Feb 1994

• Olympus Measuring Devices

  Class II

  FDA 510(k) K933717 Active Cleared 2 Nov 1993

• Sterile Disposable Cytology Brush

  Not classified

  FDA 510(k) K802187 Active Cleared 10 Sep 1980

• Olympus Infant Resectoscope and Accessories

  Class II

  FDA 510(k) K904940 Active Cleared 13 Jan 1992

See all devices from Olympus Corp. →