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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Simulation, Radiation Therapy
510(k) Number K072445
Device Name INTEGRATED BRACHYTHERAPY UNIT - DIGITAL
Applicant
Nucletron Corp.
8671 Robert Fulton Dr.
Columbia,  MD  21046
Applicant Contact LISA DIMMICK
Correspondent
Nucletron Corp.
8671 Robert Fulton Dr.
Columbia,  MD  21046
Correspondent Contact LISA DIMMICK
Regulation Number892.5840
Classification Product Code
KPQ  
Date Received08/30/2007
Decision Date 09/14/2007
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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