Deep Capsule® (Deep Capsule US) is an AI-enabled medical device from Digestaid - Artificial Intelligence Development SA that the U.S. FDA cleared through 510(k) K250655 on March 12, 2026. Its lead review panel is Gastroenterology-Urology and its primary product code is QZF (Gastrointestinal Capsule Endoscopy Analysis Software Device).
See also all FDA AI clearances in 2026, top gastroenterology-urology AI devices.
Key facts
| Submission number | K250655 |
|---|---|
| Pathway | 510(k) |
| Date of final decision | |
| Company (FDA list) | Digestaid - Artificial Intelligence Development SA |
| Lead review panel | Gastroenterology-Urology |
| Primary product code | QZF — Gastrointestinal Capsule Endoscopy Analysis Software Device |
| Applicant (openFDA) | Digestaid - Artificial Intelligence Development SA |
| Applicant location | Gondomar, PT |
| Device class | Class 2 |
| Regulation number | 21 CFR 876.1540 |
| Decision code | SESE |
| Submission type | Traditional |
Source: FDA AI-Enabled Medical Devices list and openFDA.
What this means
A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. Deep Capsule® (Deep Capsule US) went through this pathway (K250655).
openFDA lists it as a Class 2 device under 21 CFR 876.1540. Class II devices are moderate risk and are subject to general and special controls.
Product code QZF covers 2 devices on the FDA AI list. By decision date, this device is #2 of 2 under that code. Digestaid - Artificial Intelligence Development SA has 1 AI-enabled device on the list, and the Gastroenterology-Urology panel accounts for 27 in total.
Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.