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510(k) Data Aggregation

    K Number
    K212624
    Device Name
    EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
    Manufacturer
    Ever Fortune. AI Co., Ltd.
    Date Cleared
    2022-04-04

    (229 days)

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

    Ever Fortune. AI Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software for use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject. The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior (PA) chest view using an artificial intelligence algorithm. Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. The system is suitable for adults between 20 - 80 years of age. Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases.
    Device Description
    The iCTR is a non-invasive software medical device designed to be installed on the computer with specific system requirements. It is a radiological computer-assisted software system that automatically analyzes DICOM chest X-ray images in PA view and outputs the CTR through an artificial intelligence algorithm. The structure report includes a preview of the compressed chest X-ray image with the automatically-derived CTR result and annotation line, indicating the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity, and the trajectory of CTR records. The trajectory of CTR does not implement a predictive or prognostic feature.
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