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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 K011024
Device Name CYBERKNIFE SYSTEM
Applicant
ACCURAY, INC.
570 DEL REY AVE.
SUNNYVALE,  CA  94085
Applicant Contact E. BRUCE FLOYD
Correspondent
ACCURAY, INC.
570 DEL REY AVE.
SUNNYVALE,  CA  94085
Correspondent Contact E. BRUCE FLOYD
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/04/2001
Decision Date 08/10/2001
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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