K252853
- 510(k) number
- K252853
- Device name
- CAD - Lower GI (EC07-01)
- Applicant
- Xiamen Inno Medical Technology Co., Ltd. CN
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2026-08-05
- Date received
- 2025-09-08
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.8 MB · U.S. public domain
Also available from FDA: K252853.pdf
Official FDA record: K252853
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.