GI Genius— 510(k) DEN200055

Unknown

Cosmo Artificial Intelligence - Ai, Ltd.

FDA 510(k) clearance DEN200055 for GI Genius, Unknown on 2021-04-09. 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: 2020-09-08
Decision date: 2021-04-09
Decision: Unknown
Clearance type: Direct
Location: Dublin, IE

View on FDA.gov ↗

Recent devices under product code QNP

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.

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
K231143 — GI Genius System 100 and GI Genius System 2002023-05-19
K211951 — GI Genius2021-07-23

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