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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 K161146
Device Name Radixact Treatment Delivery System
Applicant
Accuray Incorporated
1209 Deming Way
Madison,  WI  53717
Applicant Contact Keith Picker
Correspondent
Accuray Incorporated
1209 Deming Way
Madison,  WI  53717
Correspondent Contact Keith Picker
Regulation Number892.5050
Classification Product Code
IYE  
Date Received04/22/2016
Decision Date 06/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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