510(k) · Cleared
ClearedME-Apds™; Magentiq-Colo™
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 Jul 25, 2023 as substantially equivalent to K211951 (Cosmo Artificial Intelligence - Ai, Ltd., 2021) after a 250-day review. Its family tree reaches back 2 generations to 2021. 3 later devices descend from it.
- Decided
- Jul 25, 2023
- Review
- 250 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200055 (2021). 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 1 generation backK211951 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- This deviceK223473 ME-Apds™; Magentiq-Colo™Magentiq Eye, Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK244023 Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2025
- Descendant · 2 generations on · 1 of its ownK252178 Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2025
- Descendant · 3 generations on · 0 of its ownK260724 Magentiq-Colo (ME-Apds)Magentiq Eye, Ltd. · 2026
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| −1 | K211951 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| 0 (this device) | K223473 | ME-Apds™; Magentiq-Colo™ | Magentiq Eye, Ltd. | 2023 | — |
| +1 | K244023 | Magentiq-Colo (ME-Apds) | Magentiq Eye, Ltd. | 2025 | — |
| +2 | K252178 | Magentiq-Colo (ME-Apds) | Magentiq Eye, Ltd. | 2025 | — |
| +3 | K260724 | Magentiq-Colo (ME-Apds) | Magentiq Eye, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 2 | 0 |
| 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 K252178 Magentiq-Colo (ME-Apds)score 14.0 · 4 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 |
|---|---|---|---|
| * | K211951 | GI GeniusSummary page 5…Name: Gastrointestinal Lesion Software Detection System Regulatory Class: II Product Code: QNP Predicate Device: Cosmo Artificial Intelligence - AI, LTD’s GI Genius (K211951) Device Description: The ME-APDS (Magentiq Eye’s Automatic Polyp Detection System) is intended to be used as an adjunct to the… | 2021 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K244023 | Magentiq-Colo (ME-Apds) | 2025 | 2 |
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 2 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K244023 (Magentiq Eye, Ltd., 2025) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K211951.
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. 2023, 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?
The 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…
Read the full statement (130 words)
The 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.
The ME-APDS is trained to process video images which may contain regions consistent with polyps.
The ME-APDS is limited for use with standard white-light endoscopy imaging only.
The 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K223473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223473: ME-Apds™; Magentiq-Colo™.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223473
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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