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510(k) Data Aggregation

    K Number
    K091403
    Device Name
    MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY
    Manufacturer
    ONCOLOGY TECH, LLC
    Date Cleared
    2009-07-29

    (78 days)

    Product Code
    IXI
    Regulation Number
    892.5710
    Why did this record match?
    Applicant Name (Manufacturer) :

    ONCOLOGY TECH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Oncology Tech precision milled brass/aluminum compensators with tungsten fillings in the compensator walls are used for modulation of beam intensity during radiation therapy.
    Device Description
    The Oncology Tech Mod1T Compensators for Radiation Beam Therapy are used for modulation of beam intensity during radiation therapy. Typically, a brass or aluminum round is used as a basis for the compensator. It is placed into the milling machine and worked into precise X, Y and Z dimensions. The new design of Oncology Tech Mod1T compensators mills out the compensator brass or aluminum walls and adds a high density material. The higher density of the fill material in the compensator walls provides for more attenuation and less radiation transmission at the field edges.
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