# DEN200055: GI Genius

- Pathway: De Novo (Direct)
- Applicant: Cosmo Artificial Intelligence - Ai, Ltd.
- Decided: Apr 9, 2021 after 213 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
No predicates in its family tree.
22 later devices descend from it; 5 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K211951: GI Genius (2021), 11 descendants of its own
- K213686: SKOUT Software (2022), 5 descendants of its own
- K231143: GI Genius System 100 and GI Genius System 200 (2023), 4 descendants of its own
- K230658: SKOUT® system (2023), 4 descendants of its own
- K240781: SKOUT® system (2024), 3 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/DEN200055
Methodology: https://510kreport.com/methodology