Cleared Special

GI Genius System 100 and GI Genius System 200

K231143 · Cosmo Artificial Intelligence - Ai, Ltd. · Gastroenterology & Urology

May 2023

Decision

28d

Days

Class 2

Risk

About This 510(k) Submission

K231143 is an FDA 510(k) clearance for the GI Genius System 100 and GI Genius System 200, a Gastrointesinal Lesion Software Detection System (Class II — Special Controls, product code QNP), submitted by Cosmo Artificial Intelligence - Ai, Ltd. (Dublin, IE). The FDA issued a Cleared decision on May 19, 2023, 28 days after receiving the submission on April 21, 2023. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1520.

Submission Details

510(k) Number	K231143 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 2023
Decision Date	May 19, 2023
Days to Decision	28 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	QNP — Gastrointesinal Lesion Software Detection System
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.1520
Definition	A Gastrointestinal Lesion Software Detection System Is A Computer-assisted Detection Device Used In Conjunction With Endoscopy For The Detection Of Abnormal Lesions In The Gastrointestinal Tract. This Device With Advanced Software Algorithms Brings Attention To Images To Aid In The Detection Of Lesions. The Device May Contain Hardware To Support Interfacing With An Endoscope.