Search Filters

Search Results

Found 3 results

510(k) Data Aggregation

    K Number
    K973963
    Device Name
    120 LEAF MULTILEAF COLLIMATOR
    Manufacturer
    MITSUBISHI ELECTRONICS AMERICA, INC.
    Date Cleared
    1998-01-14

    (90 days)

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

    MITSUBISHI ELECTRONICS AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The 120 Leaf MLC is indicated for use with the Mitsubishi EXL series linear accelerators to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer blocks.
    Device Description
    This submission is intended to be applicable to the 120 Leaf multileaf collimator system (MLC) which can be used on Mitsubishi linear accelerators for external beam radiotherapy. The MLC system is design to provide the ability to adjust the field shape to conform to tumor shapes. It can be a substitute for conventional customer provided blocks. The MLC system consists of the collimator, the Local Control Equipment (LCE) located in the treatment room, and Multi Leaf Controller Unit (MLCU). The collimator consists of three sets of jaws which determines the field size and shape. The top (Y-direction) jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The middle (X-direction) jaws also consist of a pair of monoblocks. These jaws move in tandem and determine the field length. The lower set of jaws consist of 60 pairs of leaves (120 leaves). Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.
    Ask a Question
    K Number
    K970564
    Device Name
    DYNAMIC WEDGE
    Manufacturer
    MITSUBISHI ELECTRONICS AMERICA, INC.
    Date Cleared
    1997-05-12

    (88 days)

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

    MITSUBISHI ELECTRONICS AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dynamic Wedge system is intended to be used with MLC and Mitsubishi linear accelerators with computerized consoles to provide the effective isodose curve and replace the need for traditional hard wedges.
    Device Description
    This submission is intended to be applicable to the Dynamic Wedge system which can be used with multileaf collimator system on Mitsubishi linear accelerators for external beam radiotherapy. The Dynamic Wedge system is designed to create effective isodose curve by using collimator leaf drive during irradiation. The Dynamic Wedge system consists of the collimator, motor drive unit (MDU), local control equipment (LCE) located in the treatment room, control console, and data management equipment (DME). The collimator consists of two sets of jaws which determines the field size and shape. The upper jaws consist of a pair of monoblocks just like conventional accelerator therapy collimators. The upper jaws move in tandem and determine the field length. The lower set of jaws consist of 31 pairs of leaves (62 leaves). Each pair of leaves is independently driven by a stepping motor. Each pair of leaves can be independently set to provide irregular-shaped field settings.
    Ask a Question
    K Number
    K970137
    Device Name
    EXL-12SP,12DP,15DP,20DP LINAC
    Manufacturer
    MITSUBISHI ELECTRONICS AMERICA, INC.
    Date Cleared
    1997-04-15

    (90 days)

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

    MITSUBISHI ELECTRONICS AMERICA, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The EXL series of accelerators are intended to be used for electron or photon radiation treatment of cancer.
    Device Description
    Medical Linear Accelerators provide a high energy beam of electrons and/or x-rays which is used for the treatment of cancer. The beam produced by the machine is carefully controlled in terms of geometry, energy, uniformity and intensity. The device also provides mechanisms for positioning the patient and controlling the delivery geometry. The accelerators consist of three major subsytems, the Control Console. Gantry Stand, and Rotating Gantry. The control console is the main component for operation and control of the LINAC. It is used to select the machine operation and patient treatment parameters and monitor the machine operating conditions. The new control console for the EXL-DP series of accelerators consists of an operator keyboard, video display, and various computers and control circuits. The Gantry Stand contains the high power sources for the accelerator system, notably the Klystron microwave power, modulator and electromagnet power supplies, The Rotating Gantry contains the accelerating tube, energy switching system, beam bending magnet, x-ray target, collimator, dosimetry system, and various safety features and circuits.
    Ask a Question

    Page 1 of 1