# K260724: Magentiq-Colo (ME-Apds)

- Pathway: 510(k) (Special)
- Applicant: Magentiq Eye, Ltd.
- Decided: Apr 3, 2026 after 29 days
- Product code: QNP (Gastrointesinal Lesion Software Detection System)
- Device class: 2
- Regulation: 21 CFR 876.1520
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN200055 (2021). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252178: Magentiq-Colo (ME-Apds), Magentiq Eye, Ltd. (2025) Summary page 5.

## Indications for use
ME-APDSTM (Magentiq Eye’s Automatic Polyp Detection System) is intended to be used by endoscopists as an adjunct to the common video colonoscopy procedure (screening and surveillance), aiming to assist the endoscopist in identifying lesions during colonoscopy procedure by highlighting regions with visual characteristics consistent with different types of mucosal abnormalities that appear in the colonoscopy video during the procedure. Highlighted regions can be independently assessed by the endoscopist and appropriate action taken according to standard clinical practice. ME-APDSTM is trained to process video images which may contain regions consistent with polyps. ME-APDSTM is limited for use with standard white-light endoscopy imaging only. ME-APDSTM intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.

Source page: https://510kreport.com/device/K260724
Methodology: https://510kreport.com/methodology