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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name system, image processing, radiological
510(k) Number K212758
Device Name Autoplaque
Cedars-Sinai Medical Center: AIM
8700 Beverly Blvd
Los Angeles,  CA  90048
Applicant Contact Damini Dey
Hyman, Phelps & McNamara, P.C.
700 13th Street NW
Suite 1200
Washington,  DC  20005
Correspondent Contact Philip J.H. Won
Regulation Number892.2050
Classification Product Code
Date Received08/31/2021
Decision Date 05/19/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No