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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 K123577
Device Name SYNGO.VIA MI WORKFLOWS
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 INNOVATION DR.
KNOXVILLE,  TN  37932
Applicant Contact ALAINE MEDIO, RAC
Correspondent
SIEMENS MEDICAL SOLUTIONS USA, INC.
810 INNOVATION DR.
KNOXVILLE,  TN  37932
Correspondent Contact ALAINE MEDIO, RAC
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received11/20/2012
Decision Date 01/22/2013
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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