Cleared Special

GI Genius

K211951 · Cosmo Artificial Intelligence - Ai, Ltd. · Gastroenterology & Urology

Jul 2021

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K211951 is an FDA 510(k) clearance for the GI Genius, 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 July 23, 2021, 30 days after receiving the submission on June 23, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.1520.

Submission Details

510(k) Number	K211951 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 23, 2021
Decision Date	July 23, 2021
Days to Decision	30 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.