K250655
- 510(k) number
- K250655
- Device name
- Deep Capsule® (Deep Capsule US)
- Applicant
- Digestaid - Artificial Intelligence Development SA PT
- Product code
- QZF — Gastrointestinal Capsule Endoscopy Analysis Software
- Decision date
- 2026-03-12
- Date received
- 2025-03-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 2.2 MB · U.S. public domain
Also available from FDA: K250655.pdf
Official FDA record: K250655
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.