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510(k) Data Aggregation

    K Number
    K242807
    Device Name
    HeartFocus (V.1.1.1)
    Manufacturer
    Deski
    Date Cleared
    2025-04-04

    (199 days)

    Product Code
    QJU
    Regulation Number
    892.2100
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    Applicant Name (Manufacturer) :

    Deski

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HeartFocus software is intended to assist and guide medical professionals in the acquisition of cardiac ultrasound images. HeartFocus software is an accessory to compatible general-purpose diagnostic ultrasound systems. Heartfocus guides the acquisition of two-dimensional transthoracic echocardiography (2D-TTE). Specifically, in the acquisition of the following standard views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (A4C), Apical 5-Chamber (A5C), Apical 2-Chamber (A2C), Apical 3-Chamber (A3C), Subcostal 4-Chamber (SC-4C), and Subcostal Inferior Vena Cava (SC-IVC). HeartFocus software is indicated for use in adult patients who require a cardiac ultrasound exam.
    Device Description
    The HeartFocus software is a radiological computer-assisted acquisition guidance system that provides real-time user guidance during echocardiography to assist the user in acquiring anatomically standard diagnostic-quality 2D echocardiographic views. HeartFocus software is an accessory to compatible general-purpose diagnostic ultrasound systems. HeartFocus is intended to be used by medical professionals who have received appropriate training on ultrasound basics and training on using the HeartFocus software, provided by either DESKi or by a trained medical professional while using approved training materials. It supports the acquisitions of 10 echocardiographic views: Parasternal Long-Axis (PLAX), Parasternal Short-Axis at the Aortic Valve (PSAX-AV), Parasternal Short-Axis at the Mitral Valve (PSAX-MV), Parasternal Short-Axis at the Papillary Muscle (PSAX-PM), Apical 4-Chamber (A4C), Apical 5-Chamber (A5C), Apical 2-Chamber (A2C), Apical 3-Chamber (A3C), Subcostal 4-Chamber (SC-4C), and Subcostal Inferior Vena Cava (SC-IVC). To allow the acquisition of these views, HeartFocus can connect to an ultrasound system, allowing it to receive a stream of ultrasound images. The standard views acquired with HeartFocus may be assessed by qualified medical professionals to support their decision-making regarding patient care. The collected exams can be transferred notably using DICOM protocols. HeartFocus is an application that operates entirely offline, without requiring a cloud server to provide its functionalities. All collected medical data is stored locally on the tablet. This data is never transferred to a server controlled by DESKi. It proposes 4 major functionalities to assist healthcare professionals in the acquisition of cardiac ultrasound images: Live guidance, Diagnostic-quality view detection, Auto record, and Best-effort record.
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