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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 K120233
Device Name SYNCHRONY RESPIRATORY TRACKING SYSTEM
Applicant
ACCURAY INCORPORATED
1310 chesapeake terrace
sunnyvale,  CA  94089
Contact anne schlagenhaft
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/25/2012
Decision Date 03/09/2012
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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