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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radiological Computer-Assisted Triage And Notification Software
510(k) Number K242837
Device Name BriefCase-Triage
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 Number892.2080
Classification Product Code
QAS  
Date Received09/19/2024
Decision Date 10/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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