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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Automated Radiological Image Processing Software
510(k) Number K230534
Device Name BriefCase-Quantification
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 Number892.2050
Classification Product Code
QIH  
Date Received02/27/2023
Decision Date 11/08/2023
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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