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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 K091999
Device Name CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Applicant
ACCURAY, INC.
1310 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089
Applicant Contact ANNE SCHLAGENHAFT
Correspondent
ACCURAY, INC.
1310 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089
Correspondent Contact ANNE SCHLAGENHAFT
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/02/2009
Decision Date 09/18/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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