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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 K122137
Device Name CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM CYBERKNIFE VSI ROBOTIC RADIOSURGERY SYSTEM
Original Applicant
ACCURAY INCORPORATED
1310 chesapeake terrace
sunnyvale,  CA  94089
Original Contact anne schlagenhaft
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/18/2012
Decision Date 10/26/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Radiology
Review Advisory Committee Radiology
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
Recalls CDRH Recalls
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