510(k) K253664
K253664 is an FDA 510(k) premarket notification submitted by Iterative Health for the device "SKOUT system". The FDA issued a decision of Substantially Equivalent on December 22, 2025. The device falls under product code QNP (Gastrointesinal Lesion Software Detection System), a Class II device regulated under 21 CFR 876.1520. Iterative Health has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 22, 2025
- Date Received
- November 20, 2025
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gastrointesinal Lesion Software Detection System
- Device Class
- Class II
- Regulation Number
- 876.1520
- Review Panel
- GU
- Submission Type
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.