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510(k) Data Aggregation

    K Number
    K203696
    Device Name
    RBknee
    Manufacturer
    Date Cleared
    2021-08-27

    (252 days)

    Product Code
    Regulation Number
    892.2050
    Why did this record match?
    Applicant Name (Manufacturer) :

    Radiobotics ApS

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    RBknee is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren-Lawrence grading of standing, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians.
    Device Description
    RBknee as a fully-automated image processing stand-alone software is a software device designed to assist clinicians in analyzing and measuring radiographic abnormalities during review of posterior-anterior (PA) and anterior-posterior (AP) radiographs. In brief, RBknee takes digital radiographs (AP/PA) as input and as output provides: - 1. A visual report with - a. A copy of regions of interest from the original radiographs with overlays that mark the minimum Joint Space Width (JSW) - A table with the measurement of the minimum JSW in millimeters (mm), information on the presence or absence of joint space narrowing, osteophytes, and sclerosis based on OARSI gradings, and information on the presence or absence of radiographic knee osteoarthritis (OA) based on the Kellgren-Lawrence (KL) score. - 2. A text report with - a. A textual summary of the presence or absence of joint space narrowing, osteophytes, and sclerosis based on OARSI gradings (called findings), and a textual summary of the presence or absence of radiographic knee osteoarthritis (OA) based on the Kellgren-Lawrence score (called impression). RBknee is not interpreting any results but makes an objective measurement and providing an output based on a well established scale (OARSI/KL). RBknee can be integrated to a PACS and the outputs of RBknee can be reviewed in a DICOM viewer. RBknee operates in a Linux environment and can be compatible with any operating system supporting the third-party software Docker. The integration environment has to support RBknee data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.
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