# K260567: EW10-EC02 Endoscopy Support Program

- Pathway: 510(k) (Special)
- Applicant: Fujifilm Corporation
- Decided: Aug 7, 2026 after 169 days
- Product code: QNP (Gastrointesinal Lesion Software Detection System)
- Device class: 2
- Regulation: 21 CFR 876.1520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to DEN200055 (2021). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230751: EW10-EC02 Endoscopy Support Program, Fujifilm Corporation (2023) Summary page 5.

## Indications for use
This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosa lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard WLI (White Light Imaging) and LCI (Linked Color Imaging) endoscopy imaging. This software is not intended to replace clinical decision making.

Source page: https://510kreport.com/device/K260567
Methodology: https://510kreport.com/methodology