QNP — Gastrointesinal Lesion Software Detection System Class II
FDA product code QNP covers "Gastrointesinal Lesion Software Detection System", a Class II medical device regulated under 21 CFR 876.1520. Submissions are reviewed by the Gastroenterology, Urology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QNP
- Device Class
- Class II
- Regulation Number
- 876.1520
- Submission Type
- 510(k)
- Review Panel
- GU
- Medical Specialty
- Gastroenterology, Urology
- Implant
- No
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.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K260133 | Odin Medical Limited | CADDIE | Sep 12, 2026 |
| K260567 | Fujifilm Corporation | EW10-EC02 Endoscopy Support Program | Aug 7, 2026 |
| K252853 | Xiamen Inno Medical Technology Co | CAD - Lower GI (EC07-01) | Aug 5, 2026 |
| K261369 | Cosmo Artificial Intelligence - Ai | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US) | May 29, 2026 |
| K260724 | Magentiq Eye | MAGENTIQ-COLO (ME-APDS) | Apr 3, 2026 |
| K253664 | Iterative Health | SKOUT system | Dec 22, 2025 |
| K252178 | Magentiq Eye | MAGENTIQ-COLO (ME-APDS) | Oct 3, 2025 |
| K252586 | Odin Medical Limited | CADDIE | Sep 12, 2025 |
| K251126 | Iterative Health | SKOUT system | May 9, 2025 |
| K244023 | Magentiq Eye | MAGENTIQ-COLO (ME-APDS) | Jan 24, 2025 |
| K241887 | Cosmo Artificial Intelligence - Ai | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO… | Jul 25, 2024 |
| K240044 | Odin Medical Limited | CADDIE | Jul 24, 2024 |
| K241508 | Iterative Scopes | SKOUT® system | Jul 3, 2024 |
| K240781 | Iterative Scopes | SKOUT® system | Apr 19, 2024 |
| K233964 | Cosmo Artificial Intelligence - Ai | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO… | Jan 12, 2024 |
| K230751 | Fujifilm Corporation | EW10-EC02 Endoscopy Support Program | Dec 15, 2023 |
| K223473 | Magentiq Eye | ME-APDS; MAGENTIQ-COLO | Jul 25, 2023 |
| K231143 | Cosmo Artificial Intelligence - Ai | GI Genius System 100 and GI Genius System 200 | May 19, 2023 |
| K230658 | Iterative Scopes | SKOUT® system | Apr 7, 2023 |
| K213686 | Iterative Scopes | SKOUT Software | Aug 12, 2022 |