# K103312: UPD-Y0003 - Pathway: 510(k) (Traditional) - Applicant: Olympus Medical Systems Corporation - Decided: May 12, 2011 after 183 days - Product code: FDF (Colonoscope And Accessories, Flexible/Rigid) - Device class: 2 - Regulation: 21 CFR 876.1500 - Recalls of this device: none - Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026 ## Lineage Longest line of descent: 1 generation back to K002749 (2000). 1 ancestor in all. 1 later device descends from it; 1 cites it directly. 0 of 3 devices in its family (counting itself) have a Class I recall. ## Predicates on the family tree (from the FDA summary) - K002749: Endoscope Contour Detection Device, Model 3DX45 and Colonoscope, Model XCF-Q140L/13D, The Olympus Optical Co. (2000) Summary page 2. ## Most influential descendants - K134026: Endoscope Position Marking Probe,Endoscope Position Detecting Unit (2014), 0 descendants of its own ## Indications for use This instrument has been designed to be used with Olympus endoscope systems for the detection and display of the shape of an endoscope once inserted into the patient. Patients who require colonoscopy except as follows: -Patients with a pacemaker -Pregnant women Source page: https://510kreport.com/device/K103312 Methodology: https://510kreport.com/methodology