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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K062514
Device Name CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
Applicant
ACCURAY INCORPORATED
1310 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089 -1100
Applicant Contact ANNE SCHLAGENHAFT
Correspondent
ACCURAY INCORPORATED
1310 CHESAPEAKE TERRACE
SUNNYVALE,  CA  94089 -1100
Correspondent Contact ANNE SCHLAGENHAFT
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/28/2006
Decision Date 09/28/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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