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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 K170751
Device Name MRIdian Linac System with 138-leaf Collimator
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  
Subsequent Product Code
LNH  
Date Received03/13/2017
Decision Date 06/07/2017
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
Recalls CDRH Recalls
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