GI Genius System 100 and GI Genius System 200

Cosmo Artificial Intelligence - AI Ltd · K231143 · 2023-05-19

GI Genius System 100 and GI Genius System 200 is an AI-enabled medical device from Cosmo Artificial Intelligence - AI Ltd, listed by FDA (510(k), K231143) with a decision date of 2023-05-19. Review panel: Gastroenterology-Urology.

FDA submission numberK231143
Pathway510(k)
CompanyCosmo Artificial Intelligence - AI Ltd
Review panel (specialty)Gastroenterology-Urology
FDA decision date2023-05-19
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.