510(k) · Cleared
ClearedGI Genius System 100 and GI Genius System 200
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cosmo Artificial Intelligence - Ai, Ltd. · QNP Gastrointesinal Lesion Software Detection System
Cleared on May 19, 2023 as substantially equivalent to K211951 (Cosmo Artificial Intelligence - Ai, Ltd., 2021) after a 28-day review. Its family tree reaches back 2 generations to 2021. 4 later devices descend from it.
- Decided
- May 19, 2023
- Review
- 28 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN200055 (2021). 4 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 deviceK231143 GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd. · 2023
- Descendant · cites it directly · 3 of its ownK233964 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200…Cosmo Artificial Intelligence - Ai, Ltd. · 2024
- Descendant · 2 generations on · 1 of its ownK241887 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200…Cosmo Artificial Intelligence - Ai, Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK252853 CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd. · 2026
- Descendant · 3 generations on · 0 of its ownK261369 GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd. · 2026
Most influential descendants
Showing 4 of 4 · See all- K233964GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0…Cosmo Artificial Intelligence - Ai, Ltd. · 2024 · cites it directly3descendants
- K241887GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0…Cosmo Artificial Intelligence - Ai, Ltd. · 2024 · 2 generations on1descendant
- K252853CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd. · 2026 · 2 generations on0descendants
- K261369GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US)Cosmo Artificial Intelligence - Ai, Ltd. · 2026 · 3 generations on0descendants
View 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) | K231143 | GI Genius System 100 and GI Genius System 200 | Cosmo Artificial Intelligence - Ai, Ltd. | 2023 | — |
| +1 | K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US)… | Cosmo Artificial Intelligence - Ai, Ltd. | 2024 | — |
| +2 | K241887 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US)… | Cosmo Artificial Intelligence - Ai, Ltd. | 2024 | — |
| +2 | K252853 | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | 2026 | — |
| +3 | K261369 | GI Genius™ Module 300 (GGM300-US);ColonPRO™ US (CPRO403S-US) | Cosmo Artificial Intelligence - Ai, Ltd. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
| 2026 | 2 | 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 4…ot intended to replace clinical decision making. The indications for use statement is identical to that for the original unmodified (predicate) device, as cleared under K211951. 510(k) Summary for GI Genius… | 2021 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0… | 2024 | 3 |
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 1 company; a new generation was cleared every 1.8 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K233964 (Cosmo Artificial Intelligence - Ai, Ltd., 2024) has gone furthest, with 3 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 GI Genius System is a computer-assisted reading tool designed to aid endoscopists in detecting colonic mucosal lesions (such as polyps and adenomas) in real time during standard white-light endoscopy examinations of patients undergoing screening and surveillance endoscopic mucosal evaluations. The GI Genius computer-assisted detection device is limited for use with standard white-light endoscopy imaging only. This device is not intended to replace clinical decision making.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K231143 · printed Nov 6, 2026
Cite this page
510(k) Report. “K231143: GI Genius System 100 and GI Genius System 200.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231143
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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