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510(k) Data Aggregation

    K Number
    K203502
    Device Name
    MEDO-Thyroid
    Manufacturer
    MEDO DX Pte. Ltd.
    Date Cleared
    2021-04-23

    (144 days)

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

    MEDO DX Pte. Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MEDO-Thyroid is designed to view and quantify ultrasound thyroid image data using machine learning techniques to aid in analysis of thyroid lobes and identify thyroid nodules, including evaluation, quantification and documentation of any such nodule. The device is intended to be used on adult patient images of 18 years or older.
    Device Description
    MEDO-Thyroid is a cloud-based standalone software as a medical device (SaMD) that helps qualified users with image-based assessment of thyroid ultrasound images in adult patients of 18 years and older. It is designed to support the workflow by helping the radiologist to evaluate, quantify, and generate reports for thyroid ultrasound images. MEDO-Thyroid 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 thyroid lobes and thyroid nodule volumes of single frame and multi-frame ultrasound images, as well as create and finalize examination reports. It provides users with a specific toolset for viewing ultrasound Thyroid images, placing landmarks, and creating reports. Key features of the software are: - Single and multi-frame visualization . - Cross Referencing . - . Manual and semi-automatic landmark placements - Thyroid Lobes (left and right) and thyroid nodule volume measurements ● - TI-RADS Score and Classification (based on user manual input) . - Report generation ●
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