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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 K182687
FOIA Releasable 510(k) K182687
Device Name Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
Applicant
Accuray Incorporated
1240 Deming Way
Madison,  WI  53717
Applicant Contact Keith Picker
Correspondent
Accuray Incorporated
1240 Deming Way
Madison,  WI  53717
Correspondent Contact Keith Picker
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/26/2018
Decision Date 11/23/2018
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
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