510(k) · Gastroenterology-Urology

GI Genius System 100 and GI Genius System 200

by Cosmo Artificial Intelligence - AI Ltd

GI Genius System 100 and GI Genius System 200 is an AI-enabled medical device from Cosmo Artificial Intelligence - AI Ltd that the U.S. FDA cleared through 510(k) K231143 on May 19, 2023. Its lead review panel is Gastroenterology-Urology and its primary product code is QNP (Gastrointesinal Lesion Software Detection System).

See also FDA-cleared AI gastroenterology-urology devices in 2023, all FDA AI clearances in 2023, top gastroenterology-urology AI devices.

Key facts

Submission numberK231143
Pathway510(k)
Date of final decision
Company (FDA list)Cosmo Artificial Intelligence - AI Ltd
Lead review panelGastroenterology-Urology
Primary product codeQNP — Gastrointesinal Lesion Software Detection System
Applicant (openFDA)Cosmo Artificial Intelligence - Ai, Ltd.
Applicant locationDublin, IE
Device classClass 2
Regulation number21 CFR 876.1520
Decision codeSESE
Submission typeSpecial

Source: FDA AI-Enabled Medical Devices list and openFDA.

What this means

A 510(k) is a premarket submission showing the device is substantially equivalent to a legally marketed predicate device. A cleared 510(k) means FDA agreed with that equivalence. GI Genius System 100 and GI Genius System 200 went through this pathway (K231143).

openFDA lists it as a Class 2 device under 21 CFR 876.1520. Class II devices are moderate risk and are subject to general and special controls.

Product code QNP covers 20 devices on the FDA AI list. By decision date, this device is #6 of 20 under that code. Cosmo Artificial Intelligence - AI Ltd has 6 AI-enabled devices on the list, and the Gastroenterology-Urology panel accounts for 27 in total.

Being on this list doesn't describe how well the device works clinically. Check the FDA record for its indications for use.

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