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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 K150192
Device Name Scenium
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC
810 INNOVATION DRIVE
KNOXVILLE,  TN  37932
Applicant Contact ALAINE MEDIO
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC
810 INNOVATION DRIVE
KNOXVILLE,  TN  37932
Correspondent Contact ALAINE MEDIO
Regulation Number892.2050
Classification Product Code
LLZ  
Subsequent Product Code
KPS  
Date Received01/28/2015
Decision Date 03/29/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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