# K213686: SKOUT Software

- Pathway: 510(k) (Traditional)
- Applicant: Iterative Scopes, Inc.
- Decided: Aug 12, 2022 after 263 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.
5 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)
- DEN200055: GI Genius, Cosmo Artificial Intelligence - Ai, Ltd. (2021) Summary page 4.

## Most influential descendants
- K230658: SKOUT® system (2023), 4 descendants of its own
- K240781: SKOUT® system (2024), 3 descendants of its own
- K241508: SKOUT® system (2024), 2 descendants of its own
- K251126: SKOUT system (2025), 1 descendant of its own
- K253664: SKOUT system (2025), 0 descendants of its own

## Indications for use
The SKOUT system is a software device designed to detect potential colorectal polyps in real time during colonoscopy examinations. It is indicated as a computer-aided detection tool providing colorectal polyps location information to assist qualified and trained gastroenterologists in identifying potential colorectal polyps during colonoscopy examinations in adult patients undergoing colorectal cancer screening or surveillance. The SKOUT system is only intended to assist the gastroenterologist in identifying suspected colorectal polyps and the gastroenterologist is responsible for reviewing SKOUT suspected polyp areas and confirming the presence or absence of a polyp based on their own medical judgment. SKOUT is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make a primary interpretation of endoscopic procedures, medical diagnosis, or recommendations of treatment/course of action for patients. SKOUT is indicated for white light colonoscopy only.

Source page: https://510kreport.com/device/K213686
Methodology: https://510kreport.com/methodology