GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)

Cosmo Artificial Intelligence - Ai, Ltd. · K261369 · 2026-05-29

GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) is an AI-enabled medical device from Cosmo Artificial Intelligence - Ai, Ltd., listed by FDA (510(k), K261369) with a decision date of 2026-05-29. Review panel: Gastroenterology-Urology.

FDA submission numberK261369
Pathway510(k)
CompanyCosmo Artificial Intelligence - Ai, Ltd.
Review panel (specialty)Gastroenterology-Urology
FDA decision date2026-05-29
DecisionSubstantially Equivalent
Product codeQNP
ClassificationGastrointesinal Lesion Software Detection System
Device class2
Regulation number876.1520
Review time (calendar days)32
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.