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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 K052325
Device Name CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY
Applicant
Accuray Incorporated
1310 Chesapeake Ter.
Sunnyvale,  CA  94089
Applicant Contact ANNE SCHLAGENHAFT
Correspondent
Accuray Incorporated
1310 Chesapeake Ter.
Sunnyvale,  CA  94089
Correspondent Contact ANNE SCHLAGENHAFT
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/25/2005
Decision Date 09/14/2005
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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