# K231143: GI Genius System 100 and GI Genius System 200

- Pathway: 510(k) (Special)
- Applicant: Cosmo Artificial Intelligence - Ai, Ltd.
- Decided: May 19, 2023 after 28 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.
4 later devices descend from it; 1 cites it directly.
0 of 7 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 4.

## Most influential descendants
- K233964: GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) (2024), 3 descendants of its own
- K241887: GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US); GI Genius™ Module 300 (GGM300-US); ColonPRO™ 4.0 (CPRO40S-US) (2024), 1 descendant of its own
- K252853: CAD - Lower GI (EC07-01) (2026), 0 descendants of its own
- K261369: GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) (2026), 0 descendants of its own

## Indications for use
The GI Genius System 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 white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.

Source page: https://510kreport.com/device/K231143
Methodology: https://510kreport.com/methodology