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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, stationary
510(k) Number K132934
Device Name MULTIX SELECT DR
Original Applicant
SIEMENS MEDICAL SOLUTIONS, INC.
51 valley stream parkway
malvern,  PA  19355
Original Contact patricia d jones
Regulation Number892.1680
Classification Product Code
KPR  
Date Received09/30/2013
Decision Date 04/10/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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