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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Tomography, Computed
510(k) Number K120331
Device Name SYNGO CT DYNAMIC ANGIO
Applicant
Siemens AG Medical Solutions
Henkestrasse 127, D-91052
Eriangen,  DE
Applicant Contact RALF HOFMANN
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact NORBERT STUIBER
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/02/2012
Decision Date 04/13/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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