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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 K150191
Device Name GammaBeam 500
Applicant
Best Theratronics Limited
413 March Rd.
Ottawa,  CA k2k 0e4
Applicant Contact Mike de van der Schueren
Correspondent
Best Theratronics Limited
413 March Rd.
Ottawa,  CA k2k 0e4
Correspondent Contact Mike de van der Schueren
Regulation Number892.5750
Classification Product Code
IWB  
Date Received01/28/2015
Decision Date 04/17/2015
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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