GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)
FDA 510(k) K241887 · Cosmo Artificial Intelligence - Ai, Ltd.
Submission
- Device name
- GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US)
- Applicant
- Cosmo Artificial Intelligence - Ai, Ltd.
Dublin, IE - Received
- June 28, 2024
- Decision date
- July 25, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QNP – Gastrointesinal Lesion Software Detection System
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1520
- Specialty
- Gastroenterology, Urology
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.
Other 510(k)s with product code QNP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260133 | CaddieQNP · Special | Odin Medical Limited | 09/12/2026SE |
| K260567 | EW10-EC02 Endoscopy Support ProgramQNP · Special | Fujifilm Corporation | 08/07/2026SE |
| K252853 | CAD - Lower GI (EC07-01)QNP · Traditional | Xiamen Inno Medical Technology Co., Ltd. | 08/05/2026SE |
| K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)QNP · Special | Cosmo Artificial Intelligence - Ai, Ltd. | 05/29/2026SE |
| K260724 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 04/03/2026SE |
| K253664 | SKOUT systemQNP · Special | Iterative Health | 12/22/2025SE |
| K252178 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 10/03/2025SE |
| K252586 | CaddieQNP · Special | Odin Medical Limited | 09/12/2025SE |
| K251126 | SKOUT systemQNP · Special | Iterative Health | 05/09/2025SE |
| K244023 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 01/24/2025SE |
More from Magentiq Eye, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K261369 | GI Genius Module 300 (GGM300-US);ColonPRO US (CPRO403S-US)QNP · Special | 05/29/2026SE |
| K233964 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0…QNP · Special | 01/12/2024SE |
| K231143 | GI Genius System 100 and GI Genius System 200QNP · Special | 05/19/2023SE |
| K211951 | GI GeniusQNP · Special | 07/23/2021SE |
Questions and answers
When was GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US) cleared by the FDA?
GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0 (CPRO40.US); GI Genius Module 300 (GGM300-US); ColonPRO 4.0 (CPRO40S-US) (K241887) received a 510(k) decision of Substantially Equivalent on July 25, 2024, 27 days after the submission was received.
What is the product code of K241887?
The FDA product code is QNP – Gastrointesinal Lesion Software Detection System, a Class II (moderate risk) device regulated under 21 CFR 876.1520.