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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 K231690
Device Name iCAS-LV
Applicant
Highrad , Ltd.
132 Menachem Begin Rd. Azrieli Center, Round Tower Floor 22
Tel Aviv,  IL 6702101
Applicant Contact Yossi Srour
Correspondent
Hogan Lovells US LLP
555 Thirteenth St.
Washington,  DC  20004
Correspondent Contact John J. Smith, M.D., J.D.
Regulation Number892.2050
Classification Product Code
QIH  
Date Received06/09/2023
Decision Date 03/01/2024
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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