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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
Applicant
ACCURAY INCORPORATED
1310 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089
Applicant Contact ANNE SCHLAGENHAFT
Correspondent
ACCURAY INCORPORATED
1310 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089
Correspondent Contact ANNE SCHLAGENHAFT
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/18/2012
Decision Date 10/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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