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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 K073373
Device Name SYNGO VOLUME PERFUSION-CT BODY
Applicant
Siemens AG Medical Solutions
Henkestrasse 127
Erlangen,  DE 91052
Applicant Contact RALF HOFMANN
Correspondent
Tuv Sud America, Inc.
1775 Old Highway 8 NW
New Brighton,  MN  55112 -1891
Correspondent Contact STEPHEN PREISS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received12/03/2007
Decision Date 12/18/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Abbreviated
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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