# K230751: EW10-EC02 Endoscopy Support Program

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Corporation
- Decided: Dec 15, 2023 after 273 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: 2 generations back to DEN200055 (2021). 2 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211951: GI Genius, Cosmo Artificial Intelligence - Ai, Ltd. (2021) Summary page 6.

## Most influential descendants
- K260567: EW10-EC02 Endoscopy Support Program (2026), 0 descendants of its own

## Indications for use
This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal 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 White Light Imaging (WLI) and Linked Color Imaging (LCI) endoscopy imaging. This software is not intended to replace clinical decision making.

Source page: https://510kreport.com/device/K230751
Methodology: https://510kreport.com/methodology