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510(k) Data Aggregation

    K Number
    K123371
    Device Name
    ALIGNRT PLUS
    Manufacturer
    VISION RT LIMITED
    Date Cleared
    2013-01-08

    (68 days)

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

    VISION RT LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AlignRT Plus system is indicated for use to position and monitor patients relative to the prescribed treatment isocentre, and to withhold the beam automatically during radiation delivery. For cranial treatments, a manual head adjuster is included which can be used in concert with AlignRT Plus to provide fine corrections for pitch, roll and yaw rotations. AlignRT Plus is also used to track the patient's respiratory pattern for respiratory synchronized image acquisition therapy treatment. Patient contour data can be extracted and exported from the data acquired for the purpose of treatment planning. AlignRT Plus can be calibrated directly to the treatment beam isocentre and in turn assists in performing quality assurance on MV, kV imagers, room lasers and the treatment couch. AlignRT Plus is indicated for use during simulation, setup and stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body where radiation is indicated.
    Device Description
    AlignRT Plus system is a combination of the predicate devices AlignRT (K052682) and GateCT-RT (K072171). It is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, and one, two or three 3D camera units (each camera unit comprising a stereo pair of sensors to allow 3D surface reconstruction). The system is non-invasive, does not require the use of body markers and produces no ionizing irradiation during the imaging process.
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    K Number
    K072171
    Device Name
    GATECT-RT
    Manufacturer
    VISION RT LIMITED
    Date Cleared
    2007-10-01

    (56 days)

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

    VISION RT LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GateCT-RT system is used to obtain tracking of the subject's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. It can be also used, either independently or in conjunction with Vision RT's AlignRT (K052682), to monitor the patient position during the image acquisition, simulation and treatment and to disable the radiation beam automatically.
    Device Description
    The GateCT-RT device is an attachment to radiation therapy treatment systems, simulators and image acquisition devices used for diagnostics and radiation therapy. The GateCT-RT system senses and records the respiratory motion and respiratory state of a patient using real time 3D surface tracking of the patient without the need of any externally positioned markers. Regions to be tracked are selected remotely in a location indicated by the physician on the GateCT-RT workstation. These may be automatically detected during subsequent sessions. GateCT tracks the patient's breathing CT acquisition in order to facilitate 4DCT reconstruction. GateRT tracks respiratory motion during treatment or imaging and automatically disables the beam when the breathing signal moves outside the user defined gating window. GateCT-RT may also be employed within the monitoring mode of AlignRT to disable the beam automatically if any patient movement is detected which exceeds a user defined tolerance. The Vision RT camera unit is connected to a PC workstation and is used for surface tracking of the patient.
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    K Number
    K052682
    Device Name
    ALIGNRT
    Manufacturer
    VISION RT LIMITED
    Date Cleared
    2006-01-06

    (100 days)

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

    VISION RT LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AlignRT system is used to position patients at the isocentre of the linear accelerator for radiation therapy procedures. Patient contour data can be extracted and exported from the acquired data for the purpose of treatment planning. AlignRT is used by radiotherapy professionals in appropriate hospital environments. It can be used with all types of radiotherapy patients and can image any visible anatomical region. The system is completely non-invasive and does not require the application of any external markers to the patient.
    Device Description
    AlignRT is a video-based three-dimensional (3D) surface imaging system, which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment. The system consists of advanced software, a computer workstation, two 3D camera units, cables, and templates that are used for camera calibration. The system is non-invasive, does not require the use of body markers and produces no irradiation during the imaging process. AlignRT first generates a reference surface of the optimum treatment position determined during treatment simulation. This reference image is generated by either recording the surface of a patient placed in a conventional radiotherapy simulator in which the system is installed or by importing skin contours from CT (X-Ray Computer Tomography) volumetric data generated via third party treatment planning software. Prior to each treatment session the patient's position is imaged and compared to the reference image by the system's surface matching software. Where movement from the reference position is detected the software calculates new co-ordinates to adjust the treatment couch for optimal positioning of the patient. The system is designed to interface directly with certain third party couch control systems. In order to minimise the setup errors that can result from respiratory motion, an option is available to gate the image capture of the system so that all data is acquired at a repeatable point within the breathing cycle such as the end of exhalation. Real-time imaging (1 frame/sec) of the patient is possible during the actual treatment and software verification tools are provided in order to determine any patient movement. Patient contour data may be extracted from surface data acquired by the system. In addition, lung contour data may be estimated by utilising AlignRT 3D surface data and 2D X-ray data acquired from either a conventional simulator or portal imager. These data may be exported for the purpose of treatment planning by radiotherapy professionals.
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