# K211326: EndoScreener

- Pathway: 510(k) (Traditional)
- Applicant: Chengdu Wision Medical Device Co., Ltd.
- Decided: Nov 19, 2021 after 203 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: 1 generation back to DEN200055 (2021). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN200055: GI Genius, Cosmo Artificial Intelligence - Ai, Ltd. (2021) Summary page 4.

## Indications for use
EndoScreener is intended as a stand-alone software for real-time automatic detection of polyps in colonoscopy video stream during the procedure. Physicians are responsible for reviewing the identified areas of suspect polyps presented by EndoScreener and confirming the presence or absence of a polyp on the evaluation of the colonoscopy image on the monitor and their own medical judgment. EndoScreener is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make or confirm a diagnosis. EndoScreener is indicated for use by licensed endoscopists who perform colonoscopy in adults. EndoScreener is indicated for use with white light colonoscopy.

Source page: https://510kreport.com/device/K211326
Methodology: https://510kreport.com/methodology