FDA product code QNP: Gastrointesinal Lesion Software Detection System
QNP is the FDA product code for gastrointesinal lesion software detection system. It is a Class II device, regulated under 21 CFR 876.1520 and reviewed by the Gastroenterology and Urology panel. FDA has cleared 22 510(k) submissions under QNP, 20 in the last five years, from 8 different applicants. The average 510(k) review took 109 days (median 32); 88 days on average over the last three years. 1 De Novo request was granted under it.
Definition
A gastrointestinal lesion software detection system is a computer-assisted detection device used in conjunction with endoscopy for the detection of abnormal lesions in the gastrointestinal tract. This device with advanced software algorithms brings attention to images to aid in the detection of lesions. The device may contain hardware to support interfacing with an endoscope.
Classification
| Field | Value |
|---|---|
| Device name | Gastrointesinal Lesion Software Detection System |
| Device class | Class II |
| Regulation | 21 CFR 876.1520 |
| Review panel | GU — Gastroenterology and Urology |
| Medical specialty | Gastroenterology, Urology |
| Premarket route | 510(k) |
510(k) clearances per year for QNP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2021 | 2 | 116 |
| 2022 | 1 | 263 |
| 2023 | 4 | 145 |
| 2024 | 5 | 64 |
| 2025 | 5 | 40 |
| 2026 | 5 | 160 |
Compare with all 510(k) review times · Search every QNP clearance
Top QNP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Cosmo Artificial Intelligence - Ai, Ltd. | 5 | 2026-05-29 |
| Magentiq Eye, Ltd. | 4 | 2026-04-03 |
| Iterative Scopes, Inc. | 4 | 2024-07-03 |
| Odin Medical Limited | 3 | 2026-09-12 |
| Fujifilm Corporation | 2 | 2026-08-07 |
3 more applicants have QNP clearances. See the full list in Caduvo.
Most recent QNP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260133 | Odin Medical Limited | CADDIE | 2026-09-12 | 239 |
| K260567 | Fujifilm Corporation | EW10-EC02 Endoscopy Support Program | 2026-08-07 | 169 |
| K252853 | Xiamen Inno Medical Technology Co., Ltd. | CAD - Lower GI (EC07-01) | 2026-08-05 | 331 |
| K261369 | Cosmo Artificial Intelligence - Ai, Ltd. | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | 2026-05-29 | 32 |
| K260724 | Magentiq Eye, Ltd. | MAGENTIQ-COLO (ME-APDS) | 2026-04-03 | 29 |
Recalls for QNP devices
openFDA lists no recalls for product code QNP.
Frequently asked questions
What is FDA product code QNP?
QNP is the FDA product code for gastrointesinal lesion software detection system. It is a Class II device, regulated under 21 CFR 876.1520 and reviewed by the Gastroenterology and Urology panel.
What device class is QNP?
Class II, regulation 21 CFR 876.1520. Typical premarket route: 510(k).
How long does a 510(k) take for product code QNP?
Across 22 cleared submissions the average was 109 days from receipt to decision (median 32).
Which companies have the most QNP clearances?
Cosmo Artificial Intelligence - Ai, Ltd. (5); Magentiq Eye, Ltd. (4); Iterative Scopes, Inc. (4); Odin Medical Limited (3); Fujifilm Corporation (2).
Next steps
- Run an FDA pathway report with predicate devices for product code QNP
- Run a recall and safety report across every QNP manufacturer
- Watch product code QNP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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