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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 K133259
Device Name YSIO MAX
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
51 valley stream pkwy.
malvern,  PA  19355 1406
Original Contact darren dorman
Regulation Number892.1680
Classification Product Code
KPR  
Date Received10/23/2013
Decision Date 01/24/2014
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
summary summary
Type Special
Reviewed by Third Party No
Expedited Review No
Combination Product No
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