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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 K113102
Device Name ONCENTRA MANUAL LOW DOSE RATE TREATMENT PLANNING
Applicant
Nucletron
7021 Columbia Gateway Dr.
Suite 200
Columbia,  MD  21046
Applicant Contact MICHEAL PAUL
Correspondent
Nucletron
7021 Columbia Gateway Dr.
Suite 200
Columbia,  MD  21046
Correspondent Contact MICHEAL PAUL
Regulation Number892.5050
Classification Product Code
MUJ  
Date Received10/19/2011
Decision Date 12/12/2011
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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