K240044
- 510(k) number
- K240044
- Device name
- CADDIE
- Applicant
- Odin Medical Limited GB
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2024-07-24
- Date received
- 2024-01-05
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 3.3 MB · U.S. public domain
Also available from FDA: K240044.pdf
Official FDA record: K240044
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.