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510(k) Data Aggregation

    K Number
    K052383
    Device Name
    INNOCURE IMRT FILTER (COMPENSATORS)
    Manufacturer
    Date Cleared
    2006-03-29

    (211 days)

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

    INNOCURE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Innocure Intensity Modulating Radiation Therapy Compensators are indicated to be used for external beam radiation therapy to modulate the intensity and shape of a radiation beam to compensate for missing tissue, for tissue heterogeneities, or to protect underlying tissue by intensity modulation, i.e. Intensity Modulated Radiation Therapy (IMRT).
    Device Description
    An "Innocure IMRT Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan and field identification. The Compensator device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block tray. An "Innocure IMRT Radiation Blocking Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan identification. The Blocking device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block trav. An "Innocure Radiation Wound Protective Filter™ (Compensator)" consists of a precision milled solid block of Aluminum (6061T6), a solid block of Brass 360, or a precision milled reverse Styrofoam or Polyurethane Mold filled with Molten Cerrobend or Tungsten Metal Powder identified with linear accelerator orientation markings and patient radiation therapy plan identification. The device is placed in the linear accelerator beam path between the radiation source and the patient by mounting it to a block trav.
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