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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, radiation therapy, radionuclide
510(k) Number K984563
Device Name THE CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
Applicant
ACCURAY, INC.
570 DEL REY AVE.
SUNNYVALE,  CA  94085
Applicant Contact LUANNE TERMEER
Correspondent
ACCURAY, INC.
570 DEL REY AVE.
SUNNYVALE,  CA  94085
Correspondent Contact LUANNE TERMEER
Regulation Number892.5750
Classification Product Code
IWB  
Subsequent Product Code
MUJ  
Date Received12/23/1998
Decision Date 07/14/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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