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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 K193298
Device Name BriefCase
Applicant
Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv,  IL 6706703
Applicant Contact Nimrod Epstein
Correspondent
Hogan Lovells US LLP
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John J. Smith
Regulation Number892.2080
Classification Product Code
QAS  
Date Received11/27/2019
Decision Date 06/19/2020
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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