K253664
- 510(k) number
- K253664
- Device name
- SKOUT system
- Applicant
- Iterative Health MA · US
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2025-12-22
- Date received
- 2025-11-20
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K253664.pdf
Official FDA record: K253664
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.