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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 K121074
Model 2.0
Device Name SCENIUM 2.0
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 innovation dr.
knoxville,  TN  37932
Original Contact elaine chang
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
KPS  
Date Received04/09/2012
Decision Date 06/08/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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