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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 K100637
Device Name SYNGO.CT CORONARY ANALYSIS
Applicant
SIEMENS AG, MEDICAL SOLUTIONS
SIEMENSSTRASSE 1
FORCHHEIM,  DE 91301
Applicant Contact RALF HOFMANN
Correspondent
TUV SUD AMERICA INC.
1775 OLD HIGHWAY 8 NW
NEW BRIGHTON,  MN  55112 -1891
Correspondent Contact STEFAN PREISS
Regulation Number892.1750
Classification Product Code
JAK  
Date Received03/05/2010
Decision Date 05/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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