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510(k) Data Aggregation

    K Number
    K981112
    Device Name
    MOBETRON
    Manufacturer
    INTRAOP MEDICAL, INC.
    Date Cleared
    1998-07-24

    (120 days)

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

    INTRAOP MEDICAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mobetron is a mobile electron linear accelerator that produces beams of electrons used in the radiation therapy treatment of both malignant (cancer) and benign conditions. The Mobetron has four electron beam treatment energies and a set of electron applicators which provide a range of field sizes from 3 to 10 cm in diameter. For delivery of electron beam radiation during a surgical procedure, known as Intraoperative Radiation Therapy (IORT), the Mobetron system includes a sterile cap and sterile drapes for each IORT procedure, IORT applicators, a QA system, a surgical table extender with added support leg, and bolus material.
    Device Description
    The MOBETRON is a mobile electron beam accelerator designed specifically for use in the operating room (O.R.). Once in the OR, the accelerator head can be positioned in the horizontal plane, rotated about the coronal plane, and moved along the beam axis direction to facilitate docking with an electron applicator that is inserted into the patient. Together with the C-arm rotation, the accelerator head motion is designed to allow the accelerator to be easily and safely positioned for intraoperative treatments. All motorized motions are variable speed and are controlled by a lightweight hand-held control. The operator control system contains the dosimetry readout parameters, accelerator controls, machine interlock status, and a video output of the periscopic viewing system. When the electrons emerge from the accelerator, they are scattered by a set of thin metallic foils and are pre-collimated to a circular field size of 10 cm. (at the standard treatment distance of 50 cm. SSD) by a primary tungsten collimator. The scattered electron beam passes through two independent transmission ion chambers and is further collimated to the desired field size by electron applicators which are inserted into the patient. The scattering foil and collimation technique and applicator systems used in the Mobetron is similar to techniques used for IORT in other electron accelerator systems. The Mobetron provides four (4) electron beams of energy 4, 6, 9 and 12 MeV, and a set of electron applicators of various diameters from 3 cm to enable the delivery of Intraoperative Radiotherapy (IORT) treatment.
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