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GI Genius System 100 and GI Genius System 200

by Cosmo Artificial Intelligence - Ai, Ltd. FDA registration: Ireland 510(k)

510(k) K231143 Product code QNP

Overview

The GI Genius System 100 and GI Genius System 200 is a gastrointestinal lesion software detection system. It is an artificial intelligence-based device trained to process colonoscopy images to identify regions consistent with colorectal lesions.

This device is regulated under FDA 510(k) clearance, identified by K231143. It is classified as a class 2 medical device under regulation number 876.1520 and is intended for use within the fields of gastroenterology and urology.

Summary written by AI from registry data, 22 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK231143 Date19 May 2023ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k) · synced 22 Oct 2026

510(k) Number
FDA Product Code
QNP
Device Class
Class II
Regulation
21 CFR Part 876.1520
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Cosmo Artificial Intelligence, Ltd

Questions

  • What is the primary function of the GI Genius System?

    The GI Genius System 100 and 200 is an artificial intelligence-based software detection system. It is designed to process images captured during a colonoscopy to assist clinicians by identifying regions that are consistent with colorectal lesions.

  • What is the regulatory status of this device?

    This device is regulated under FDA 510(k) clearance, identified by K231143. It is classified as a class 2 medical device under regulation number 876.1520, intended for use within the fields of gastroenterology and urology.

  • Which medical specialties is this software intended for?

    The GI Genius System is intended for use within the fields of gastroenterology and urology. It functions as a gastrointestinal lesion software detection system to support clinical procedures in these areas.

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K231143 24 fields · synced 22 Oct 2026