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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
Recalls CDRH Recalls
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