GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US)

Cosmo Artificial Intelligence - AI Ltd · K233964 · 2024-01-12

GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0 (CPRO40.US) is an AI-enabled medical device from Cosmo Artificial Intelligence - AI Ltd, listed by FDA (510(k), K233964) with a decision date of 2024-01-12. Review panel: Gastroenterology-Urology.

FDA submission numberK233964
Pathway510(k)
CompanyCosmo Artificial Intelligence - AI Ltd
Review panel (specialty)Gastroenterology-Urology
FDA decision date2024-01-12
DecisionSubstantially Equivalent
Product codeQNP
ClassificationGastrointesinal Lesion Software Detection System
Device class2
Regulation number876.1520
Review time (calendar days)28
Applicant countryIE

Official FDA database record · FDA AI-enabled device list

More devices from Cosmo Artificial Intelligence - AI Ltd · All Gastroenterology-Urology AI devices · Full device index

Data from FDA's AI-enabled device list and openFDA. Informational only; verify against the FDA record.