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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Gastrointesinal Lesion Software Detection System
510(k) Number K251126
Device Name SKOUT system
Applicant
Iterative Health
14 Arrow Street, Floor 3
Cambridge,  MA  02138
Applicant Contact Caitlyn Seidl
Correspondent
Hogan Lovells US LLP
1735 Market Street, Floor 23
Philadelphia,  PA  19103
Correspondent Contact Janice Hogan
Regulation Number876.1520
Classification Product Code
QNP  
Date Received04/11/2025
Decision Date 05/09/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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