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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 K223473
Device Name ME-APDS™; MAGENTIQ-COLO™
Applicant
Magentiq Eye LTD
6 Ben Gurion Blvd.
Haifa,  IL 3541416
Applicant Contact Dror Zur
Correspondent
Hogan Lovells US LLP
Columbia Square, 555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number876.1520
Classification Product Code
QNP  
Date Received11/17/2022
Decision Date 07/25/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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