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510(k) Data Aggregation

    K Number
    K233521
    Device Name
    QT ECG (QTERD100)
    Manufacturer
    QT Medical Inc.
    Date Cleared
    2023-12-06

    (35 days)

    Product Code
    DXH, DRX
    Regulation Number
    870.2920
    Why did this record match?
    Applicant Name (Manufacturer) :

    QT Medical Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The QT ECG System is intended to acquire, record and process an electrocardiographic signal so that it can be transmitted digitally via Bluetooth technology to a cell-phone or mobile device, then to a remote location. The QT ECG System is indicated for use on infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), and in professional healthcare facilities (such as clinics, hospitals, and ambulances) to record and transmit a 12- lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.
    Device Description
    The QT ECG system is a non-defibrillator-proof, hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The QT ECG system consists of 5 maior components: - The QT ECG Recorder-Compact device that records 12-lead, resting electrocardiograms, then transmits the recorded data to a mobile device (smartphone, tablet, etc.) paired via Bluetooth. A Bluetooth-enabled mobile device (not included) is needed to operate the QT ECG Recorder, and to send the recorded rhythm strip to a cardiologist or licensed physician for review. - The QT ECG Electrode Strip-Disposable, patented electrodes that are prepositioned on a self-adhesive strip. - The QT ECG App - Software that lets the user uses their mobile device to operate the QT ECG recorder, then send the recorded data via cloud to a certified medical professional for review. - Analysis The analysis module provides ECG measurement from the collected data. It does not make any interpretation of the intervals provided based on factors such as heart rate, QRS duration, etc. - Web Service - The web service provides an interface for communication. The recorded ECG data is saved temporarily on the mobile device until it is transferred via the Internet to the cloud server. The QT ECG System does not have monitoring capabilities and does not have diagnostic alarm function. The QT ECG System is indicated for use on infants, children and adults. It is designed to be operated by adults in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), and in professional healthcare facilities (such as clinics, hospitals, and ambulances) to record and transmit a 12- lead ECG and rhythm strip in near real-time to enable review at a physician's office, hospital or other medical receiving centers.
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