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510(k) Data Aggregation

    K Number
    K131150
    Device Name
    CURA COMPENSATOR
    Manufacturer
    CURA MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2013-07-30

    (98 days)

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

    CURA MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cura Compensator is a solid, machine-shaped acrylic block intended to attenuate external radiation beam and block radiation from hitting critical structures and healthy tissue while allowing the radiation dose to the targeted area. The Cura Compensator may be used as an accessory whenever external beam radiation therapy is indicated for the treatment of patients with localized tumors or other conditions susceptible to treatment by radiation.
    Device Description
    Cura Compensators are custom beam blocks with machined cutout to allow beam passage per prescription and sized to attenuate and block all remaining beam in the radiation field. The Compensator is made of acrylic or wax with notch to match radiation machine manufacturer use specifications. No software is included in this device.
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    K Number
    K123893
    Device Name
    CURA COLLIMATOR
    Manufacturer
    CURA MEDICAL TECHNOLOGIES, LLC
    Date Cleared
    2013-03-04

    (76 days)

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

    CURA MEDICAL TECHNOLOGIES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cura Collimator is a solid, machine-shaped brass aperture intended to shape an external radiation beam to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area. The Cura Collimator may be used as an accessory whenever external beam radiation therapy is indicated for the treatment of patients with localized tumors or other conditions susceptible to treatment by radition.
    Device Description
    Cura Collimators are custom beam blocks with machined cutout to allow beam passage per prescription and sized to snugly fit the applicator or nozzle and block all remaining beam in the radiation therapy fraction delivery. The Collimator is made of high lead content brass with notch orientation to match radiation manufacturer use specifications. No software is included in this device.
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