Deep Capsule® (Deep Capsule US) is an AI-enabled medical device from Digestaid - Artificial Intelligence Development SA, listed by FDA (510(k), K250655) with a decision date of 2026-03-12. Review panel: Gastroenterology-Urology.
| FDA submission number | K250655 |
|---|---|
| Pathway | 510(k) |
| Company | Digestaid - Artificial Intelligence Development SA |
| Review panel (specialty) | Gastroenterology-Urology |
| FDA decision date | 2026-03-12 |
| Decision | Substantially Equivalent |
| Product code | QZF |
| Classification | Gastrointestinal Capsule Endoscopy Analysis Software Device |
| Device class | 2 |
| Regulation number | 876.1540 |
| Review time (calendar days) | 372 |
| Applicant country | PT |
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.