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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 K832503
Device Name CLINAC 1800
Applicant
Varian Assoc., Inc.
2700 Mitchell Dr.
Walnut Creek,  CA  94598
Correspondent
Varian Assoc., Inc.
2700 Mitchell Dr.
Walnut Creek,  CA  94598
Regulation Number892.5050
Classification Product Code
IYE  
Date Received07/25/1983
Decision Date 09/12/1983
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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