510(k) · Cleared
ClearedMagentiq-Colo (ME-Apds)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magentiq Eye, Ltd. · QNP Gastrointesinal Lesion Software Detection System
Cleared on Oct 3, 2025 as substantially equivalent to K244023 (Magentiq Eye, Ltd., 2025) after an 84-day review. Its family tree reaches back 4 generations to 2021. 1 later device descends from it.
- Decided
- Oct 3, 2025
- Review
- 84 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN200055 (2021). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 3 generations backK211951 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 2 generations backK223473 ME-Apds™; Magentiq-Colo™Magentiq Eye, Ltd. · 2023
- 1 generation backK244023 Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2025
- This deviceK252178 Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK260724 Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260724Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| −3 | K211951 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| −2 | K223473 | ME-Apds™; Magentiq-Colo™ | Magentiq Eye, Ltd. | 2023 | — |
| −1 | K244023 | Magentiq-Colo (ME-Apds) | Magentiq Eye, Ltd. | 2025 | — |
| 0 (this device) | K252178 | Magentiq-Colo (ME-Apds) | Magentiq Eye, Ltd. | 2025 | — |
| +1 | K260724 | Magentiq-Colo (ME-Apds) | Magentiq Eye, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in QNP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new QNP device
- #1 K240781 SKOUT® systemscore 13.8 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K244023 | Magentiq-Colo (ME-Apds)Summary page 5…tion Name: Gastrointestinal Lesion Software Detection System Regulatory Class: II Product Code: QNP Predicate Device: Magentiq Eye’s Automatic Polyp Detection System (K244023) Device Description: ME-APDSTM/MAGENTIQ-COLO is intended to be used as an adjunct to the common video colonoscopy procedure. Th… | 2025 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260724 | Magentiq-Colo (ME-Apds) | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 4 years and passes through 2 companies; a new generation was cleared every 1.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K260724 (Magentiq Eye, Ltd., 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All QNP devicesQNP Gastrointesinal Lesion Software Detection System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QNP
5in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QNP
28in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QNP
No recall names QNP since 2007.
Adverse event reports per year · QNP
1in 2024
MAUDE reports naming product code QNP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 3 | — | 0 | 0 |
| 2022 | 1 | — | 0 | 0 |
| 2023 | 4 | 140 | 0 | 0 |
| 2024 | 5 | 29 | 0 | 1 |
| 2025 | 5 | 28 | 0 | 0 |
| 2026 | 5 | 169 | 0 | — |
What is it indicated for?
ME-APDS (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…
Read the full statement (126 words)
ME-APDS (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-APDS is trained to process video images which may contain regions consistent with polyps.
ME-APDS is limited for use with standard white-light endoscopy imaging only.
ME-APDS is intended to be used as an adjunct to endoscopy procedures and is not intended to replace histopathological sampling as means of diagnosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K252178 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252178: Magentiq-Colo (ME-Apds).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252178
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026