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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer
510(k) Number K234141
Device Name AISAP Cardio V1.0
Applicant
Aisap
The Heart Center, Sheba Medical Center
Tel Hashomer
Ramat Gan,  IL 52621
Applicant Contact Robert Klempfner
Correspondent
Hogan Lovells
555 Thirteenth Street, NW
Washington,  DC  20004
Correspondent Contact John Smith
Regulation Number892.2060
Classification Product Code
POK  
Subsequent Product Code
QIH  
Date Received12/29/2023
Decision Date 08/01/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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