Endoscopy
SKOUT system
Iterative Health
FDA
FDA-cleared AI medical device
Computer-aided detection software that analyzes colonoscopy video in real time to mark potential colorectal polyps, intended to assist gastroenterologists during colorectal-cancer screening colonoscopy in adult patients.
FDA Submission Metadata
- Submission number
- K253664
- Decision date
- December 2025
- FDA panel
- Gastroenterology-Urology
- Product code
- QNP
This entry's identity, manufacturer, and clearance have been verified against primary regulatory sources. A full editorial deep-dive — performance, clinical evidence, and safety record — may follow.
Regulatory Approvals
FDA