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510(k) Data Aggregation

    K Number
    K233676
    Device Name
    Us2.v2
    Manufacturer
    Eko.ai Pte. Ltd d/b/a Us2.ai
    Date Cleared
    2024-04-01

    (137 days)

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

    Eko.ai Pte. Ltd d/b/a Us2.ai

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural parameters, including left right atrial and ventricular linear dimensions, volumes, systolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients.
    Device Description
    Us2.v2 is an image post-processing analysis software device used for viewing and quantifying cardiovascular ultrasound images in DICOM format. The device is intended to aid diagnostic review and analysis of echocardiographic data, patient record management and reporting. The primary intended function of Us2.v2 is to automatically provide clinically relevant and reproducible quantitative echocardiographic measurements, while reducing echocardiographic analysis time. In doing so, the primary benefit of Us2.v2 is to improve clinical echocardiographic workflow, enabling clinicians to generate and edit reports faster. with precision and with full control. Because Us2.v2 measurements cover the minimum echocardiographic dataset f or a standard adult echocardiogram (by European Society of Cardiovascular Imaging, British Society of Echocardiography and American Society of Echocardiography guidelines), our software is applicable to the vast majority of adult transthoracic echocardiograms. Our current sof tware aims to automate measurements of cardiac dimensions and lef t ventricular function and are applicable regardless of normal or disease states. We specifically indicate that our current product will not be reporting measurements associated with intra-cardiac lesions ( e.g. tumours, thrombi), nor complex adult congenital heart disease. The sof tware provides automated markup and analysis to generate a f ull report, on which a qualif ied sonographer/ reviewing physician could perf orm edits/ revise the markup on the echocardiographic image measurement during their approval process. The markup includes: the cardiac segments captured. measurements of distance, time, area and blood flow. quantitative analysis of cardiac function, and a summary report. The software allows the sonographer to enter their markup manually. It also provides automated markup and analysis, which the sonographer may choose to accept outright, to accept partially and modify, or to reject and ignore. Machine learning based view classification and border detection form the basis for this automated analysis. Additionally, the software has features for organizing, displaying and comparing to reference guidelines the quantitative data from cardiovascular images acquired from ultrasound scanners.
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