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510(k) Data Aggregation

    K Number
    K220795
    Device Name
    QT ECG
    Manufacturer
    QT Medical, Inc.
    Date Cleared
    2022-09-26

    (192 days)

    Product Code
    DXH
    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 facilities), 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 OT ECG system is a non-defibrillator-proof, hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The OT ECG system consists of 5 major 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 recoded 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, ORS 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 intended for use on infants, children and adults patients to acquire ECG signals to be transmitted wirelessly via Bluetooth to a mobile device, and then over the Internet to a web service. The QT ECG System is designed to be used by a patient to record and transmit ECG data to a physician's office, hospital or other medical receiving center for review.
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    K Number
    K200722
    Device Name
    PCA-C1 series Patient Cable
    Manufacturer
    QT Medical, Inc.
    Date Cleared
    2021-06-03

    (441 days)

    Product Code
    DSA
    Regulation Number
    870.2900
    Why did this record match?
    Applicant Name (Manufacturer) :

    QT Medical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    PCA-C100 Patient Cable is intended to be used with QT ECG device. The Patient Cable is used to connect electrodes placed at appropriate sites on the patient to an ECG device for general diagnostic evaluation by healthcare professionals.
    Device Description
    The PCA-C100 Patient Cable is a reusable ECG patient cable that is used to transmit cardiac electrical signals (ECG) from electrodes, which are affixed to the patient's body for both diagnostic purposes. The PCA-C100 Patient Cable is a crucial part of the system used diagnose the cardiac electrical signal (ECG). It allows a safe connection between the electrodes on the patient and QT ECG (K180157). The PCA-C100 Patient Cable is composed of three components: Snap - Connected with Leadwire and commercial ECG electrode. Leadwire - fitted with Trunk, and connected with ten Snaps. Trunk - Fitted with two ends: one of them connects the QT ECG (K180157); and the other end connects the Leadwires.
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    K Number
    K180157
    Device Name
    QT ECG
    Manufacturer
    QT Medical, Inc.
    Date Cleared
    2018-05-04

    (105 days)

    Product Code
    DXH
    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 adult patients and pediatric patients age 18 - 22 years. It is designed to be used by a patient or other layperson in the home, or by healthcare workers in non-acute care clinical facilities (such as nursing homes, skilled nursing facilities), 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 hand-held, cordless 12-lead electrocardiograph (ECG) system with Bluetooth connectivity. The OT ECG system consists of 5 major components when using: - 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 recoded 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. Once an ECG recording is done, the data is auto uploaded to the cloud for analysis. - . Analysis - The analysis module provides ECG measurement from the collected data. - . 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 OT ECG System does not have monitoring capabilities and does not have diagnostic alarm function. The QT ECG System is intended for use on adults and pediatric patients to acquire ECG signals to be transmitted wirelessly via Bluetooth to a mobile device, and then over the Internet to a web service. The QT ECG System is designed to be used by a patient to record and transmit ECG data to a physician's office, hospital or other medical receiving center for review.
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