K233964
- 510(k) number
- K233964
- Device name
- GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)
- Applicant
- Cosmo Artificial Intelligence - Ai, Ltd. IE
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2024-01-12
- Date received
- 2023-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.2 MB · U.S. public domain
Also available from FDA: K233964.pdf
Official FDA record: K233964
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.