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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Tomography, Computed, Emission
510(k) Number K123433
Device Name CEDARS-SINAI CARDIAC SUITE NUCLEAR MEDICINE SOFTWARE
Applicant
Cedars-Sinai Medical Center
8700 Beverly Blvd.
Los Angeles,  CA  90048
Applicant Contact GEOFF POLLARD, PROGRAM MANAGER
Correspondent
Cedars-Sinai Medical Center
8700 Beverly Blvd.
Los Angeles,  CA  90048
Correspondent Contact GEOFF POLLARD, PROGRAM MANAGER
Regulation Number892.1200
Classification Product Code
KPS  
Date Received11/07/2012
Decision Date 02/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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