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510(k) K261369

GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) by Cosmo Artificial Intelligence - Ai, Ltd. — Product Code QNP

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: May 29, 2026
Date Received: April 27, 2026
Clearance Type: Special
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Gastrointesinal Lesion Software Detection System
Device Class: Class II
Regulation Number: 876.1520
Review Panel: GU
Submission Type

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.

Other clearances by Cosmo Artificial Intelligence - Ai, Ltd.

K241887 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO (July 25, 2024)
K233964 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO (January 12, 2024)
K231143 — GI Genius System 100 and GI Genius System 200 (May 19, 2023)
K211951 — GI Genius (July 23, 2021)
DEN200055 — GI Genius (April 9, 2021)

Other clearances for product code QNP

K260724 — MAGENTIQ-COLO (ME-APDS) (April 3, 2026)
K253664 — SKOUT system (December 22, 2025)
K252178 — MAGENTIQ-COLO (ME-APDS) (October 3, 2025)
K252586 — CADDIE (September 12, 2025)
K251126 — SKOUT system (May 9, 2025)
K244023 — MAGENTIQ-COLO (ME-APDS) (January 24, 2025)
K241887 — GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO (July 25, 2024)
K240044 — CADDIE (July 24, 2024)
K241508 — SKOUT® system (July 3, 2024)
K240781 — SKOUT® system (April 19, 2024)