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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 K884323
Device Name XIMAVIEW(TM)
Applicant
Varian Assoc., Inc.
611 Hansen Way
P.O. Box 10800
Palo Alto,  CA  94303
Applicant Contact MILTON D SIEGEL
Correspondent
Varian Assoc., Inc.
611 Hansen Way
P.O. Box 10800
Palo Alto,  CA  94303
Correspondent Contact MILTON D SIEGEL
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received10/14/1988
Decision Date 04/03/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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