K260567
- 510(k) number
- K260567
- Device name
- EW10-EC02 Endoscopy Support Program
- Applicant
- Fujifilm Corporation JP
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2026-08-07
- Date received
- 2026-02-19
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain
Also available from FDA: K260567.pdf
Official FDA record: K260567
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.