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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Radiation Therapy, Radionuclide
510(k) Number K053485
Device Name THERATRON EQUINOX, MODELS 80 CM AND 100 CM
Applicant
MDS NORDION INC.
447 MARCH ROAD
OTTAWA, ONTARIO,  CA K2K 1X8
Applicant Contact ROSS KACHANIWSKY
Correspondent
MDS NORDION INC.
447 MARCH ROAD
OTTAWA, ONTARIO,  CA K2K 1X8
Correspondent Contact ROSS KACHANIWSKY
Regulation Number892.5750
Classification Product Code
IWB  
Date Received12/15/2005
Decision Date 03/09/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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