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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Instrument, Quality-Assurance, Radiologic
510(k) Number K844620
Device Name BDS-3 BEAM DATA SCANNER
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 Number892.1940
Classification Product Code
LHO  
Date Received11/27/1984
Decision Date 07/01/1985
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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