K230751
- 510(k) number
- K230751
- Device name
- EW10-EC02 Endoscopy Support Program
- Applicant
- Fujifilm Corporation JP
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2023-12-15
- Date received
- 2023-03-17
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K230751.pdf
Official FDA record: K230751
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.