GI Genius System 100 and GI Genius System 200— 510(k) K231143

Name: FDA 510(k) clearance K231143
Creator: U.S. Food and Drug Administration
Published: 2023-05-19

Substantially Equivalent

Cosmo Artificial Intelligence - Ai, Ltd.

FDA 510(k) clearance K231143 for GI Genius System 100 and GI Genius System 200, Substantially Equivalent on 2023-05-19. Applicant: Cosmo Artificial Intelligence - Ai, Ltd.. Device class: 2.

Clearance details

Applicant: Cosmo Artificial Intelligence - Ai, Ltd.
Product code: Code QNP
Device class: Class 2
Regulation: 21 CFR 876.1520
Advisory panel: Gastroenterology, Urology
Date received: 2023-04-21
Decision date: 2023-05-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Dublin, IE

Download summary PDF View on FDA.gov ↗

Recent devices under product code QNP

view all

K260133 — CADDIE2026-09-12
K260567 — EW10-EC02 Endoscopy Support Program2026-08-07
K252853 — CAD - Lower GI (EC07-01)2026-08-05
K261369 — GI Genius Module 300 (GGM300-US); ColonPRO US (CPRO403S-US)2026-05-29
K260724 — MAGENTIQ-COLO (ME-APDS)2026-04-03

More clearances from Cosmo Artificial Intelligence - Ai, Ltd.

view all

K241887 — GI Genius Module 100 (GGM100.US) +4 more2024-07-25
K233964 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US)2024-01-12
K211951 — GI Genius2021-07-23
DEN200055 — GI Genius2021-04-09

Data sourced from openFDA. This site is unofficial and independent of the FDA.