510(k) K250655 · QZF Gastrointestinal Capsule Endoscopy Analysis Software Device
Deep Capsule® (Deep Capsule US)
| Applicant | Digestaid - Artificial Intelligence Development SA, Gondomar, PT |
| Decision | Substantially Equivalent, Mar 12, 2026 |
| Received | Mar 5, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K250655
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.