K252586
- 510(k) number
- K252586
- Device name
- CADDIE
- Applicant
- Odin Medical Limited GB
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2025-09-12
- Date received
- 2025-08-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
510(k) Summary (official FDA PDF): K252586.pdf
Official FDA record: K252586
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.