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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 K152488
Device Name Onrad Treatment System
Applicant
Accuray Incorporated
1209 Deming Way
Madison,  WI  53717
Applicant Contact ERIN DALY
Correspondent
Accuray Incorporated
1209 Deming Way
Madison,  WI  53717
Correspondent Contact ERIN DALY
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received08/31/2015
Decision Date 09/28/2015
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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