SKOUT system is an AI-enabled medical device from Iterative Health, listed by FDA (510(k), K253664) with a decision date of 2025-12-22. Review panel: Gastroenterology-Urology.
| FDA submission number | K253664 |
|---|---|
| Pathway | 510(k) |
| Company | Iterative Health |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2025-12-22 |
| Decision | Substantially Equivalent |
| Product code | QNP |
| Classification | Gastrointesinal Lesion Software Detection System |
| Device class | 2 |
| Regulation number | 876.1520 |
| Review time (calendar days) | 32 |
| Applicant country | US |
Official FDA database record · FDA AI-enabled device list
All Gastroenterology-Urology AI devices · Full device index
Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.