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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K242203
Device Name BriefCase-Quantification
Applicant
Aidoc Medical , Ltd.
3 Aminadav St.
Tell-Aviv,  IL 6706703
Applicant Contact Amalia Schreier
Correspondent
Hogan Lovells US LLP
555 Thirteenth St., NW
Washington, Dc,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2050
Classification Product Code
QIH  
Date Received07/26/2024
Decision Date 11/22/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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