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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 K121513
Device Name MULTIX FUSION
Applicant
SIEMENS MEDICAL SOLUTION
51 valley stream pkwy.
malvern,  PA  19355
Contact patricia d jones
Regulation Number892.1680
Classification Product Code
KPR  
Date Received05/21/2012
Decision Date 08/10/2012
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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