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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 K162393
Device Name The ViewRay (MRIdian) Linac System
Applicant
Viewray, Incorporated
2 Thermo Fisher Way
Oakwood Village,  OH  44146
Applicant Contact SEAN DELANEY
Correspondent
Viewray, Incorporated
2 Thermo Fisher Way
Oakwood Village,  OH  44146
Correspondent Contact SEAN DELANEY
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/26/2016
Decision Date 02/24/2017
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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