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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K964138
Device Name VARIAN XIMATRON C-SERIES RADIATION THERAPY SIMULATOR WITH VERSION 4.2 SOFTWARE
Applicant
Varian Medical Systems, Inc.
Gatwick Rd.
Crawley, West Sussex,  GB
Applicant Contact CHARLES H WILL
Correspondent
Varian Medical Systems, Inc.
Gatwick Rd.
Crawley, West Sussex,  GB
Correspondent Contact CHARLES H WILL
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received10/15/1996
Decision Date 01/10/1997
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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