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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 K181989
Device Name MRIdian Linac System
Applicant
Viewray, Incorporated
815 E Middlefield Rd.
Mountain View,  CA  94043
Applicant Contact Sean Delaney
Correspondent
Viewray, Incorporated
815 E Middlefield Rd.
Mountain View,  CA  94043
Correspondent Contact Sean Delaney
Regulation Number892.5050
Classification Product Code
IYE  
Subsequent Product Code
LNH  
Date Received07/26/2018
Decision Date 02/20/2019
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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