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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 K123922
Device Name SYNGO DYNAMICS
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
400 W. MORGAN ROAD
SUITE 100
ann arbor,  MI  48108 -9117
Applicant Contact yuri ikeda
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
new brighton,  MN  55112 -1891
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received12/20/2012
Decision Date 01/16/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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