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510(k) DEN200055

GI Genius by Cosmo Artificial Intelligence - Ai, Ltd. — Product Code QNP

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
April 9, 2021
Date Received
September 8, 2020
Clearance Type
Direct
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)

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)