Deep Capsule® (Deep Capsule US)— 510(k) K250655
Substantially EquivalentDigestaid - Artificial Intelligence Development SA
FDA 510(k) clearance K250655 for Deep Capsule® (Deep Capsule US), Substantially Equivalent on 2026-03-12. Applicant: Digestaid - Artificial Intelligence Development SA. Device class: 2.
Summary
Digestaid - Artificial Intelligence Development's Deep Capsule® (Deep Capsule US) is filed under QZF, gastrointestinal capsule endoscopy analysis software devices. The record doesn't describe the software beyond its name and that code name.
Class II, 21 CFR 876.1540. It was a Traditional 510(k), and Gastroenterology and Urology is both the classification panel and the review panel.
Digestaid - Artificial Intelligence Development filed from Gondomar, Portugal. The decision came 372 calendar days after FDA received it (March 5, 2025 to March 12, 2026).
Clearance details
- Applicant
- Digestaid - Artificial Intelligence Development SA
- Product code
- Product code QZF
- Device class
- Class 2
- Regulation
- 21 CFR 876.1540
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Gondomar, PT
Recent devices under product code QZF
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