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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 K102150
Device Name SYNGO DYNAMICS, VERSION 9.0
Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
400 W. MORGAN ROAD
ANN ARBOR,  MI  48108
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 Received07/29/2010
Decision Date 10/05/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Recalls CDRH Recalls
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