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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Applicator, Radionuclide, Remote-Controlled
510(k) Number K112420
Device Name ONCENTRA PROSTATE 4.0
Applicant
Nucletron
7021 Columbia Gateway Dr.
Suite 200
Columbia,  MD  21046
Applicant Contact MICHAEL PAUL
Correspondent
Nucletron
7021 Columbia Gateway Dr.
Suite 200
Columbia,  MD  21046
Correspondent Contact MICHAEL PAUL
Regulation Number892.5700
Classification Product Code
JAQ  
Date Received08/23/2011
Decision Date 11/18/2011
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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