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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
FOIA Releasable 510(k) K212758
Device Name Autoplaque
Applicant
Cedars-Sinai Medical Center: AIM
8700 Beverly Blvd
Los Angeles,  CA  90048
Applicant Contact Damini Dey
Correspondent
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
LLZ  
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
Predetermined Change
Control Plan Authorized		 No
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