# K252853: CAD - Lower GI (EC07-01)

- Pathway: 510(k) (Traditional)
- Applicant: Xiamen Inno Medical Technology Co., Ltd.
- Decided: Aug 5, 2026 after 331 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: 4 generations back to DEN200055 (2021). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K233964: GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US), Cosmo Artificial Intelligence - Ai, Ltd. (2024) Summary page 5.
- DEN200055: GI Genius, Cosmo Artificial Intelligence - Ai, Ltd. (2021) Summary page 5.

## Indications for use
CAD - Lower GI is a computer-assisted reading tool intended to aid qualified endoscopists in detecting suspected colonic mucosal lesions, such as polyps and adenomas, in real-time endoscopic images obtained during colorectal endoscopy. The device is intended for use in adult patients undergoing colorectal cancer screening or surveillance colonoscopy in medical institutions. The device detects and displays areas of suspected lesions to assist endoscopists during colorectal endoscopy. The device is not intended to characterize lesions or replace clinical judgment. Physicians shall evaluate the device output together with the endoscopic images and other clinical information and shall not make clinical decisions solely based on the device output. The product is intended to be used only with specified compatible image processors and video endoscopes under white light and NBI modes.

Source page: https://510kreport.com/device/K252853
Methodology: https://510kreport.com/methodology