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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 K001006
Device Name THERATRON 780C/1000 WITH COMPUTERIZED CONSOLE UPGRADE
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 Number892.5750
Classification Product Code
IWB  
Date Received03/29/2000
Decision Date 04/27/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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