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510(k) Data Aggregation

    K Number
    K023430
    Device Name
    UF BRACHYTHERAPY STAND
    Date Cleared
    2003-06-24

    (256 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    UNIVERSITY OF FLORIDA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The UF Brachytherapy Stand is intended to be used to provide ultrasound probe alignment in planning and performing a prostate brachytherapy implant procedure.
    Device Description
    The UF Brachytherapy Stand is a manual, mechanical system that includes an ultrasound probe stabilizing stand and a stepping unit. It is for use clamped to a table top or side-rails.
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