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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Planning, Radiation Therapy Treatment
510(k) Number K010682
Device Name HELAX-TMS V 5.1 RADIATION THERAPY TREATMENT PLANNING SYSTEM
Applicant
Mds Nordion
447 March Rd.
Ottawa,  CA k2k 1x8
Applicant Contact E.S. MARTELL
Correspondent
Mds Nordion
447 March Rd.
Ottawa,  CA k2k 1x8
Correspondent Contact E.S. MARTELL
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received03/07/2001
Decision Date 06/05/2001
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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