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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 Prioritization Software For Lesions
510(k) Number K230020
Device Name BriefCase
Applicant
Aidoc Medical, Ltd.
3 Aminadav St.
Tel-Aviv,  IL 6706703
Applicant Contact Amalia Schreier
Correspondent
Hogan Lovells U.S. LLP
555 Thirteenth Street NW
Washington,  DC  20004
Correspondent Contact John J Smith
Regulation Number892.2080
Classification Product Code
QFM  
Date Received01/03/2023
Decision Date 02/01/2023
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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