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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 K113758
Device Name VOLUSON E6/E8/E8EXPERT/E10
Applicant
GE HEALTHCARE
9900 innovation drive
wauwatosa,  WI  53226
Contact bryan behn
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
NEU  
Date Received12/21/2011
Decision Date 01/10/2012
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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