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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 K113029
Device Name SYNGO VIA MI WORKFLOWS
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
2501 north barrington rd.
hoffman estates,  IL  60192
Original Contact alaine medio
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received10/20/2011
Decision Date 11/18/2011
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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