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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 K252178
Device Name MAGENTIQ-COLO (ME-APDS)
Applicant
Magentiq Eye, Ltd.
6 Ben Gurion Blvd.
Haifa,  IL 3541416
Applicant Contact Dror Zur
Correspondent
Hogan Lovells US LLP
555 13th St. NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number876.1520
Classification Product Code
QNP  
Date Received07/11/2025
Decision Date 10/03/2025
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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