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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 K111862
FOIA Releasable 510(k) K111862
Device Name VIEWRAY SYSTEM
Applicant
Viewray, Incorporated
2 Thermo Fisher Way
Oakwood Village,  OH  44146
Applicant Contact JANICE BROWNLEE
Correspondent
Viewray, Incorporated
2 Thermo Fisher Way
Oakwood Village,  OH  44146
Correspondent Contact JANICE BROWNLEE
Regulation Number892.5050
Classification Product Code
IYE  
Date Received06/30/2011
Decision Date 05/22/2012
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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