SKOUT system
FDA 510(k) K251126 · Iterative Health
510(k) numberK251126
Submission
- Device name
- SKOUT system
- Applicant
- Iterative Health
Cambridge, MA, US - Received
- April 11, 2025
- Decision date
- May 9, 2025
- 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 |
| K244023 | Magentiq-Colo (Me-Apds)QNP · Special | Magentiq Eye, Ltd. | 01/24/2025SE |
| K241887 | GI Genius Module 100 (GGM100.US); GI Genius Module 200 (GGM200.US); ColonPRO 4.0…QNP · Special | Cosmo Artificial Intelligence - Ai, Ltd. | 07/25/2024SE |
More from Cosmo Artificial Intelligence - Ai, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253664 | SKOUT systemQNP · Special | 12/22/2025SE |
Questions and answers
When was SKOUT system cleared by the FDA?
SKOUT system (K251126) received a 510(k) decision of Substantially Equivalent on May 9, 2025, 28 days after the submission was received.
What is the product code of K251126?
The FDA product code is QNP – Gastrointesinal Lesion Software Detection System, a Class II (moderate risk) device regulated under 21 CFR 876.1520.