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510(k) Data Aggregation

    K Number
    K030609
    Device Name
    MODULEAF
    Manufacturer
    MRC SYSTEMS GMBH
    Date Cleared
    2003-03-17

    (19 days)

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

    MRC SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ModuLeaf is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The ModuLeaf is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate the radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs.
    Device Description
    The ModuLeaf is a conformal radiation therapy and radiosurgery device that is mounted to a standard radiation therapy linear accelerator (Linac). The ModuLeaf receives input from planning system software that determines the collimator aperture shapes at different gantry positions along the arc around the target area. Radiation is delivered at a constant rate. The ModuLeaf consists of three parts: (1) the user console, (2) the control cabinet and (3) the collimator mechanism. The control cabinet with the user console serves as the control station for the operator and is located near the Linac operator console. The control cabinet contains the PC, an interface board and the power supply. The PC consists of a specified configuration of a CPU, motherboard. RAM, VGA board and HDD. It is used as the communication interface between the operator and the planning system software or the record and verify (R&V) system that contains the treatment positioning data. The PC also serves as the master for the control and verification system. The data received from the planning system software or the record and verify (R&V) system is processed and transferred to the micro-controllers on the control and verification boards. The operator initiates position adjustment at the console or at the record and verify (R&V) system depending on the configuration. When an R&V system is involved the leaf positions are downloaded to the PC. The PC then starts all the micro-controllers simultaneously and retrieves the position of the leaves, comparing the values of the control system with those of the verification system. The collimator mechanism is fitted to the accessory holder of the Linac gantry. It consists of 80 driving units that position the tunqsten leaves via a rack and pinion mechanism. Two independent potentiometers are directly connected with each tungsten leaf to retrieve information on the leaf position, i.e. there are 80 potentiometers for leaf positioning and an additional 80 potentiometers for independent leaf position verification. They serve as feedback for the verification system that checks the correct positioning of the leaves.
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    K Number
    K022307
    Device Name
    KONRAD, MODEL V.2.0
    Manufacturer
    MRC SYSTEMS GMBH
    Date Cleared
    2002-10-08

    (84 days)

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

    MRC SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    KonRad is intended to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). Once the optimization is complete the dose distribution and dose volume histogram curves are displayed for the user to evaluate. After approval the results are exported to the delivery equipment, Linear Accelerator or Record and Verify system, for final verification before treatment delivery.
    Device Description
    KonRad as described in this submission is a radiation therapy treatment planning package designed to optimize multi-leaf collimator (MLC) positions or partial attenuation block shapes for intensity modulated external beam radiation therapy (IMRT). KonRad is a PC based system. KonRad software uses defined anatomical structures for the optimization and treatment planning process. The images or contours are based on tomographic images imported via Dicom and Dicom RT protocols from various sources, e.g. CT. Virtual Simulation software etc. The users treatment machine beam data is utilized for plan calculation. The user defines the desired dose to be delivered to the target and the surrounding structures. Values are entered to weight the optimizations according to the importance of reaching the dose objectives for the target and other structures. After the user starts the optimization, the software calculates the required MLC or partial attenuation block shapes needed to achieve the dose objectives. This is done for each beam simultaneously and the resulting dose distribution and DVH are displayed. Once the optimization is complete, the dose distribution and DVH are displayed for the user to evaluate. If the user is not satisfied with the results of the optimization, the input parameters can be modified and the optimization repeated until the desired results are met. When the user is statisfied, the final treatment plan can be stored and is ready for export. The resulting treatment plan can be exported, to the appropriate delivery equipment. Linear Accelerator or Record and Verify system (R&V) via defined protocols, e.g. Dicom RT. The export of the treatment plan does not activate the delivery equipment, all information must be verified by the user prior to treatment.
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    K Number
    K011816
    Device Name
    MINI MULTILEAF COLLIMATOR, MODEL KMI
    Manufacturer
    MRC SYSTEMS GMBH
    Date Cleared
    2001-09-07

    (88 days)

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

    MRC SYSTEMS GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mini Multileaf Collimator is a conformal radiation therapy and radiosurgery device that delivers a shaped X-ray beam from a radiation therapy source. The Mini Multileaf Collimator is attached to a linear accelerator and consists of a series of pairs of tungsten leaves that collimate radiation delivery to a target based on a treatment plan generated by planning software. The device is used to help the clinician deliver well-defined target volumes of radiation while sparing the surrounding tissues and organs. The Mini Multileaf Collimator should only be used for fixed field X-ray treatments.
    Device Description
    The Mini Multileaf Collimator is a conformal radiosurgery device that is a line to The Mini Multical Oonlinator to erapy linear accelerator (Linac). The Mini Multileaf Collimator mounted to a standard racines that determines the collimator aperture shapes at different gantry positions along the arc around the target area. Radiation is delivered at a constant rate. The Mini Multileaf Collimator consists of three parts: (1) the user console, (2) the control cabinet and (3) the collimator mechanism. The control cabinet with the user console serve as the control station for the operator and are I he control cabinet will the user console. The control cabinet contains the PC, an interface board located the power supply. The PC consists of a specified configuration of a CPU, motherboard, and the power supply. The F & consisted interface between the operator and the planning system software that contains the treatment positioning data. The PC also serves as the master for the control and verification system. The data received from the planning system software is processed and transferred to the micro-controllers (MC) on the control and verification boards. The operator at the console initiates position adjustment. The PC then starts all the MC's I'm operator at the consore innussion of the leaves, comparing the values of the control system with those of the verification system. The collimator mechanism is fitted to the accessory holder of the Linac gantry. It consists of 80 I it conmitte that position the fitted to theaves via a rack and pinion mechanism. A potentioneter is directly connected with each tungsten leaf to retrieve information on the leaf position. Independent potentiometers for verification are also included in the driving units.
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