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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 K963451
Device Name ANTI-TUMOR EXPERT SYSTEM (ATES) FOR RADIATION THERAPY TREATMENT PLANNING
Applicant
Topslane
824 Ruth Dr.
Pleasnat Hill,  CA  94523
Applicant Contact ANN ZENG
Correspondent
Topslane
824 Ruth Dr.
Pleasnat Hill,  CA  94523
Correspondent Contact ANN ZENG
Regulation Number892.5050
Classification Product Code
IYE  
Date Received09/03/1996
Decision Date 08/05/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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