K241508
- 510(k) number
- K241508
- Device name
- SKOUT® system
- Applicant
- Iterative Scopes, Inc. MA · US
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2024-07-03
- Date received
- 2024-05-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.6 MB · U.S. public domain
Also available from FDA: K241508.pdf
Official FDA record: K241508
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.