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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 K032345
Device Name CYBERKNIFE SYSTEM FOR STEROTACTIC RADIOSURGERY/RADIOTHERAPY
Applicant
Accuray, Inc.
570 Del Rey Ave.
Sunnyvale,  CA  94085
Applicant Contact ANNE SCHLAGENHAFT
Correspondent
Accuray, Inc.
570 Del Rey Ave.
Sunnyvale,  CA  94085
Correspondent Contact ANNE SCHLAGENHAFT
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received07/30/2003
Decision Date 09/03/2003
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
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