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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 K982713
Device Name RT DESKTOP
Applicant
Elekta Oncology Systems, Ltd.
8 Executive Park W.
Suite 809
Atlanta,  GA  30329
Applicant Contact PAUL L SUMNER
Correspondent
Elekta Oncology Systems, Ltd.
8 Executive Park W.
Suite 809
Atlanta,  GA  30329
Correspondent Contact PAUL L SUMNER
Regulation Number892.5050
Classification Product Code
IYE  
Date Received08/04/1998
Decision Date 11/02/1998
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
Recalls CDRH Recalls
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