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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 K121934
Model H-0000-0003
Device Name TOMOTHERAPY TREATMENT SYSTEM
Original Applicant
ACCURAY INCORPORATED
1209 deming way
madison,  WI  53717
Original Contact greg bange
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received07/16/2012
Decision Date 08/29/2012
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
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