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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K102915
FOIA Releasable 510(k) K102915
Device Name VIEWRAY TREATMENT PLANNING AND DELIVERY 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
MUJ  
Date Received10/01/2010
Decision Date 01/12/2011
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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