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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 K920041
Device Name ADAC XL-PLAN-PC
Applicant
Adac Laboratories
540 Alder Dr.
Milpitas,  CA  95035
Applicant Contact PAUL VICHA
Correspondent
Adac Laboratories
540 Alder Dr.
Milpitas,  CA  95035
Correspondent Contact PAUL VICHA
Regulation Number892.5050
Classification Product Code
IYE  
Date Received01/06/1992
Decision Date 03/30/1992
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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