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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 THERMOFISHER WAY
OAKWOOD,  OH  44146
Applicant Contact JANICE BROWNLEE
Correspondent
VIEWRAY INCORPORATED
2 THERMOFISHER WAY
OAKWOOD,  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
Recalls CDRH Recalls
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