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510(k) Data Aggregation

    K Number
    K200356
    Device Name
    MEDO ARIA
    Manufacturer
    Date Cleared
    2020-06-11

    (119 days)

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

    Medo.ai

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    MEDO ARIA is designed to view and quantify ultrasound image data using machine learning techniques to aid trained medical professionals in diagnosis of developmental dysplasia of the hip (DDH). The device is intended to be used on neonates and infants, aged 0 to 12 months.
    Device Description
    MEDO ARIA is a cloud-based standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of developmental hip dysplasia (DDH) of pediatric patients (e.g., ages 0 to 12 months). It is designed to support the workflow by helping the radiologist to evaluate, quantify, and generate reports for hip images. MEDO ARIA Software takes as an input imported Digital Imaging and Communications in Medicine (DICOM) images from ultrasound scanners and allows users to upload, browse, and view images, measure alpha angle and acetabular coverage, and manipulate 2D and 3D infant hip ultrasound images, as well as create and finalize examination reports. It provides users with a specific toolset for viewing pediatric ultrasound hip images, placing landmarks, and creating reports.
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