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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
FOIA Releasable 510(k) K121074
Device Name SCENIUM 2.0
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 INNOVATION DR.
KNOXVILLE,  TN  37932
Applicant Contact ELAINE CHANG
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 INNOVATION DR.
KNOXVILLE,  TN  37932
Correspondent 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 (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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