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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 K100714
Device Name CSMC CARDIAC SUITE-NUCLEAR MEDICINE SOFTWARE APPLICATON MODEL 2010-01
Applicant
Cedars-Sinai Medical Center
8787 Southside Blvd., #719
Jacksonville,  FL  32256
Applicant Contact DAVID R DILLS
Correspondent
Cedars-Sinai Medical Center
8787 Southside Blvd., #719
Jacksonville,  FL  32256
Correspondent Contact DAVID R DILLS
Regulation Number892.1200
Classification Product Code
KPS  
Date Received03/12/2010
Decision Date 04/01/2011
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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