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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name accelerator, linear, medical
510(k) Number K121295
Model 04475930
Device Name ARTISTETM SOLUTION WITH SYS VCIO
Original Applicant
SIEMENS MEDICAL SOLUTIONS USA, INC.
4040 nelson ave.
concord,  CA  94520
Original Contact christine dunbar
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/30/2012
Decision Date 06/27/2012
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
Recalls CDRH Recalls
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