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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
Original Applicant
SIEMENS AG, MEDICAL SOLUTIONS
henkestrasse 127
erlangen,  GM d-91052
Original Contact ralf hofmann
Regulation Number892.1750
Classification Product Code
JAK  
Date Received02/02/2012
Decision Date 04/13/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party Yes
Expedited Review No
Combination Product No
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