# K134026: Endoscope Position Marking Probe,Endoscope Position Detecting Unit

- Pathway: 510(k) (Traditional)
- Applicant: Olympus Medical Systems Corp.
- Decided: Mar 7, 2014 after 67 days
- Product code: PGU (Spatial Imaging For Display Of Endoscope Position)
- 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: 2 generations back to K002749 (2000). 2 ancestors in all.
No later device cites it as a predicate yet.
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.
- K103312: UPD-Y0003, Olympus Medical Systems Corporation (2011) Summary page 2.

## Indications for use
This instrument has been designed to be used with an Olympus endoscope and the endoscope position detecting unit for detection and display of the location and/or shape of the inserted endoscope. 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 and enteroscopy except as follows: Patients with a critical active implantable device such as a pacemaker and an implantable cardioverter defibrillator Pregnant women

Source page: https://510kreport.com/device/K134026
Methodology: https://510kreport.com/methodology