Endoscopy
Deep Capsule (Deep Capsule US)
DigestAID - Artificial Intelligence Development, S.A.
FDA
FDA-cleared AI medical device
AI software that analyzes capsule-endoscopy video to detect and differentiate lesions during review, intended to assist clinicians reading capsule-endoscopy studies.
FDA Submission Metadata
- Submission number
- K250655
- Decision date
- March 2026
- FDA panel
- Gastroenterology-Urology
- Product code
- QZF
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA