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510(k) K240044

CADDIE by Odin Medical Limited — Product Code QNP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 2024
Date Received
January 5, 2024
Clearance Type
Traditional
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 Odin Medical Limited

  • K252586 — CADDIE (September 12, 2025)

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)
  • K241508 — SKOUT® system (July 3, 2024)
  • K240781 — SKOUT® system (April 19, 2024)
  • K233964 — GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ (January 12, 2024)