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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
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