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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 K062967
FOIA Releasable 510(k) K062967
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
MUJ  
Subsequent Product Code
IYE  
Date Received09/29/2006
Decision Date 10/30/2006
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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