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510(k) Data Aggregation

    K Number
    K092550
    Device Name
    TIGRT IVS
    Manufacturer
    LINATECH, LLC
    Date Cleared
    2009-12-15

    (118 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    LINATECH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.
    Device Description
    TiGRT IVS is intended to be used in conjunction with Linac and Digital Panel for analyzing the current patient position and calculating the patient positioning shift correction factor, as well as the treatment portal verification and record.
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    K Number
    K090893
    Device Name
    TIGRT TPS
    Manufacturer
    LINATECH, LLC
    Date Cleared
    2009-07-15

    (106 days)

    Product Code
    MUJ
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    LINATECH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. TiGRT TPS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray and/or electron energies from 1 to 25MV, as well as Cobalt-60.
    Device Description
    TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. TiGRT TPS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray and/or electron energies from 1 to 25MV, as well as Cobalt-60.
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    K Number
    K090802
    Device Name
    TIGRT MLC, TIGRT DMLC
    Manufacturer
    LINATECH, LLC
    Date Cleared
    2009-07-07

    (105 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Why did this record match?
    Applicant Name (Manufacturer) :

    LINATECH, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TIGRT MLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
    Device Description
    TIGRT MLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.
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