K252178
- 510(k) number
- K252178
- Device name
- MAGENTIQ-COLO (ME-APDS)
- Applicant
- Magentiq Eye, Ltd. IL
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2025-10-03
- Date received
- 2025-07-11
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.1 MB · U.S. public domain
Also available from FDA: K252178.pdf
Official FDA record: K252178
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.