510(k) · Cleared
ClearedCAD - Lower GI (EC07-01)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Xiamen Inno Medical Technology Co., Ltd. · QNP Gastrointesinal Lesion Software Detection System
Cleared on Aug 5, 2026 as substantially equivalent to K233964 (Cosmo Artificial Intelligence - Ai, Ltd., 2024) and 1 other predicate after a 331-day review. Its family tree reaches back 4 generations to 2021.
- Decided
- Aug 5, 2026
- Review
- 331 days
- Class
- Class II
- Product code
- QNP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to DEN200055 (2021). No later device cites it as a predicate yet.
- Root · 4 generations backDEN200055 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 3 generations backK211951 GI GeniusCosmo Artificial Intelligence - Ai, Ltd. · 2021
- 2 generations backK231143 GI Genius System 100 and GI Genius System 200Cosmo Artificial Intelligence - Ai, Ltd. · 2023
- 1 generation backK233964 GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200…Cosmo Artificial Intelligence - Ai, Ltd. · 2024
- This deviceK252853 CAD - Lower GI (EC07-01)Xiamen Inno Medical Technology Co., Ltd. · 2026
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 | 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 | — |
| 0 (this device) | K252853 | CAD - Lower GI (EC07-01) | Xiamen Inno Medical Technology Co., Ltd. | 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? (2)
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 |
|---|---|---|---|
| * | K233964 | GI Genius™ Module 100 (GGM100.US); GI Genius™ Module 200 (GGM200.US); ColonPRO™ 4.0…Summary page 5…n Name: Gastrointestinal Lesion Software Detection System Regulatory Class: Class II Product Code: QNP Premarket Notification: K233964 Manufacturer: Cosmo Artificial Intelligence - AI Ltd IV Predicate Device 2 Trade/Device Name:… | 2024 |
| * | DEN200055 | GI GeniusSummary page 5…Regulation Name: Gastrointestinal Lesion Software Detection System Regulatory Class: Class II Product Code: QNP Submission Number: DEN200055 Manufacturer: Cosmo Artificial Intelligence - AI, LTD… | 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 4 ancestors has a recall.
- 1 other device also cites its predicate K233964.
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?
CAD - Lower GI is a computer-assisted reading tool intended to aid qualified endoscopists in detecting suspected colonic mucosal lesions, such as polyps and adenomas, in real-time endoscopic images obtained during colorectal endoscopy. The device is intended for use in adult patients undergoing colorectal cancer screening or surveillance colonoscopy in medical institutions. The device detects and displays areas of suspected lesions to assist endoscopists…
Read the full statement (128 words)
CAD - Lower GI is a computer-assisted reading tool intended to aid qualified endoscopists in detecting suspected colonic mucosal lesions, such as polyps and adenomas, in real-time endoscopic images obtained during colorectal endoscopy.
The device is intended for use in adult patients undergoing colorectal cancer screening or surveillance colonoscopy in medical institutions.
The device detects and displays areas of suspected lesions to assist endoscopists during colorectal endoscopy. The device is not intended to characterize lesions or replace clinical judgment. Physicians shall evaluate the device output together with the endoscopic images and other clinical information and shall not make clinical decisions solely based on the device output.
The product is intended to be used only with specified compatible image processors and video endoscopes under white light and NBI modes.
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/K252853 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252853: CAD - Lower GI (EC07-01).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252853
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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