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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 K081018
Device Name SYNGO DYNAMICS VERSION 7.0
Applicant
Siemens Medical Solutions
400 W. Morgan Rd., Suite 100
Ann Arbor,  MI  48108
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 Received04/10/2008
Decision Date 04/25/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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