K241887
- 510(k) number
- K241887
- Device name
- GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)
- Applicant
- Cosmo Artificial Intelligence - Ai, Ltd. IE
- Product code
- QNP — Gastrointesinal Lesion Software Detection System
- Decision date
- 2024-07-25
- Date received
- 2024-06-28
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- Gastroenterology, Urology
PDFDownload 510(k) SummaryArchived here · 1.3 MB · U.S. public domain
Also available from FDA: K241887.pdf
Official FDA record: K241887
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.