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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 K070322
Device Name SYNGO DYNAMICS, VERSION 6.0
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
400 W. MORGAN ROAD
SUITE 100
ANN ARBOR,  MI  48108 -9117
Applicant Contact SIEGLINDE NINA WEST
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.2050
Classification Product Code
LLZ  
Date Received02/02/2007
Decision Date 02/27/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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