510(k) · Cleared
ClearedEndoScreener
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Chengdu Wision Medical Device Co., Ltd. · QNP Gastrointesinal Lesion Software Detection System
Cleared on Nov 19, 2021 as substantially equivalent to DEN200055 (Cosmo Artificial Intelligence - Ai, Ltd., 2021) after a 203-day review. Its family tree reaches back 1 generation to 2021.
- Decided
- Nov 19, 2021
- Review
- 203 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN200055 (2021). No later device cites it as a predicate yet.
- Root · 1 generation backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- This deviceK211326 EndoScreenerChengdu Wision Medical Device Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN200055 | GI Genius | Cosmo Artificial Intelligence - Ai, Ltd. | 2021 | — |
| 0 (this device) | K211326 | EndoScreener | Chengdu Wision Medical Device Co., Ltd. | 2021 | — |
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 |
|---|---|---|---|
| * | DEN200055 | GI GeniusSummary page 4…ps Classification Name: Gastrointestinal lesion software detection system Regulatory Class: Class II (21 CFR 876.1520) Product Code: QNP Predicate Device: GI Genius (DEN 200055) Device Description The EndoScreener is a computer-assisted detection device for colorectal polyps. EndoScreener takes as input… | 2021 |
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?
- Its one ancestor has no recall.
- 4 other devices also cite its predicate DEN200055.
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. 2021, 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?
EndoScreener is intended as a stand-alone software for real-time automatic detection of polyps in colonoscopy video stream during the procedure.
Physicians are responsible for reviewing the identified areas of suspect polyps presented by EndoScreener and confirming the presence or absence of a polyp on the evaluation of the colonoscopy image on the monitor and their own medical judgment. EndoScreener is not intended to replace a full patient evaluation, nor is it intended to be relied upon to make or confirm a diagnosis.
EndoScreener is indicated for use by licensed endoscopists who perform colonoscopy in adults. EndoScreener is indicated for use with white light colonoscopy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211326 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211326: EndoScreener.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211326
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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