510(k) · Cleared
ClearedEW10-EC02 Endoscopy Support Program
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Corporation · QNP Gastrointesinal Lesion Software Detection System
Cleared on Aug 7, 2026 as substantially equivalent to K230751 (Fujifilm Corporation, 2023) after a 169-day review. Its family tree reaches back 3 generations to 2021.
- Decided
- Aug 7, 2026
- Review
- 169 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to DEN200055 (2021). No later device cites it as a predicate yet.
- Root · 3 generations backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 2 generations backK211951 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 1 generation backK230751 EW10-EC02 Endoscopy Support ProgramFujifilm Corporation · 2023
- This deviceK260567 EW10-EC02 Endoscopy Support ProgramFujifilm Corporation · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| −2 | K211951 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| −1 | K230751 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2023 | — |
| 0 (this device) | K260567 | EW10-EC02 Endoscopy Support Program | Fujifilm Corporation | 2026 | — |
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 |
|---|---|---|---|
| * | K230751 | EW10-EC02 Endoscopy Support ProgramSummary page 5…876.1520 Product Code(s) QNP I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K230751 EW10-EC02 Endoscopy Support Program QNP Device Description Summary 21 CFR 807.92(a)(4) A. Intended Use/indications for Use B. D… | 2023 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 years and passes through 2 companies; a new generation was cleared every 2.4 years on median.
- None of the 3 ancestors has a recall.
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. 2026, 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?
This software is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosa lesions (such as polyps and adenomas) in real time during standard endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. This software is used with standard WLI (White Light Imaging) and LCI (Linked Color Imaging) endoscopy imaging. This software is not intended to replace clinical decision making.
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/K260567 · printed Nov 5, 2026
Cite this page
510(k) Report. “K260567: EW10-EC02 Endoscopy Support Program.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K260567
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026