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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 K222329
Device Name BriefCase
Applicant
Aidoc Medical, Ltd.
3 Aminadav St.,
Tel Aviv,  IL 6706703
Applicant Contact Amalia Schreie
Correspondent
Hogan Lovells US LLP
555 Thirteenth St
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number892.2080
Classification Product Code
QAS  
Date Received08/02/2022
Decision Date 09/28/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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