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510(k) Data Aggregation

    K Number
    K063839
    Device Name
    POSITIONER
    Manufacturer
    C-RAD POSITIONING AB
    Date Cleared
    2007-02-08

    (44 days)

    Product Code
    IYE
    Regulation Number
    892.5050
    Type
    Traditional
    Panel
    Radiology
    Reference & Predicate Devices
    K052682
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Positioner system is intended for use in radiation therapy clinics to accurately position patients for radiation therapy in a teproducible way. The system provides information about a patient's position and the adjustments required in order to position the patient as a close as possible to a reference setup. The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostics departments.

    Device Description

    The system consists of a laser-camera unit (LS-100) mounted in the ceiling, and a Windows based application (cPosition) running on a standard PC. The system is non-invasive and uses visible laser light (635nm) to project lines on the patient. The laser-camera scans a 3D surface by projecting a series of laser lines which are recorded by the camera. From each camera recording a 3D contour of the measured object is calculated using triangulation technique and by adding the contours a full 3D surface image is achieved. The PC software compares the scanned image with a reference image and calculates the adjustments required in order to match the two images.

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study that proves the device meets the acceptance criteria. The document is a 510(k) summary for a medical device called "Positioner", which describes its intended use, technological comparison to predicate devices, and the FDA's substantial equivalence determination.

    The document states: "However, performance data has been submitted to show that Positioner achieves its intended use and that these technological differences raise no new efficacy or safety concerns." This indicates that a performance study was conducted and submitted to the FDA, but the details of the acceptance criteria and the study results are not present in this summary.

    Therefore, I cannot extract the information required in your request, such as a table of acceptance criteria, sample sizes, expert qualifications, or details about standalone or MRMC studies.

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