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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 K901932
Device Name VARIAN ELECTRONIC PORTAL IMAGING SYSTEM
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 Number892.5050
Classification Product Code
IYE  
Date Received04/30/1990
Decision Date 05/03/1991
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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