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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 K212794
Device Name Accuray Precision Treatment Planning System
Applicant
Accuray Incorporated
1209 Deming Way
Madison,  WI  53717
Applicant Contact Lizhi Yu
Correspondent
Accuray Incorporated
1209 Deming Way
Madison,  WI  53717
Correspondent Contact Lizhi Yu
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
MUJ  
Date Received09/02/2021
Decision Date 09/30/2021
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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