QNP — Gastrointesinal Lesion Software Detection System Class II
Classification Details
- Product Code
- QNP
- Device Class
- Class II
- Regulation Number
- 876.1520
- Submission Type
- 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 |
|---|---|---|---|
| K260724 | magentiq eye | MAGENTIQ-COLO (ME-APDS) | April 3, 2026 |
| K253664 | iterative health | SKOUT system | December 22, 2025 |
| K252178 | magentiq eye | MAGENTIQ-COLO (ME-APDS) | October 3, 2025 |
| K252586 | odin medical limited | CADDIE | September 12, 2025 |
| K251126 | iterative health | SKOUT system | May 9, 2025 |
| K244023 | magentiq eye | MAGENTIQ-COLO (ME-APDS) | January 24, 2025 |
| K241887 | cosmo artificial intelligence - ai | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO | July 25, 2024 |
| K240044 | odin medical limited | CADDIE | July 24, 2024 |
| K241508 | iterative scopes | SKOUT® system | July 3, 2024 |
| K240781 | iterative scopes | SKOUT® system | April 19, 2024 |
| K233964 | cosmo artificial intelligence - ai | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO | January 12, 2024 |
| K230751 | fujifilm corporation | EW10-EC02 Endoscopy Support Program | December 15, 2023 |
| K223473 | magentiq eye | ME-APDS; MAGENTIQ-COLO | July 25, 2023 |
| K231143 | cosmo artificial intelligence - ai | GI Genius System 100 and GI Genius System 200 | May 19, 2023 |
| K230658 | iterative scopes | SKOUT® system | April 7, 2023 |
| K213686 | iterative scopes | SKOUT Software | August 12, 2022 |
| K211326 | chengdu wision medical device co | EndoScreener | November 19, 2021 |
| K211951 | cosmo artificial intelligence - ai | GI Genius | July 23, 2021 |
| DEN200055 | cosmo artificial intelligence - ai | GI Genius | April 9, 2021 |