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510(k) Data Aggregation

    K Number
    K191692
    Device Name
    KardioScreen
    Date Cleared
    2020-01-10

    (199 days)

    Product Code
    Regulation Number
    870.2340
    Why did this record match?
    Applicant Name (Manufacturer) :

    iMedrix Inc. (formerly Piitech Inc.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    KardioScreen is a portable and mobile device intended to acquire a resting, diagnostic ECG using surface electrodes from adult patients and pediatric patients age 14-21 years. The device is intended to be used by doctors and/or trained healthcare professionals in a hospital, medical professional's facility, clinic, physician's office or any medical outreach center. The device can acquire, display, analyze and print either 6-lead or 12-lead electrocardiograms which can be exported for external use. The recorded ECG signals can help users to analyze and diagnose heart disease, but the device is not meant as a sole means of diagnosis.
    Device Description
    KardioScreen is a portable battery-operated electrocardiograph designed to acquire either a 6lead or 12-lead resting, diagnostic electrocardiogram (ECG) using surface electrodes from adult patients and pediatric patients aged 14-21 years. The device consists of the following three (3) parts: - 1. Electrodes and patient cable with KardioScreen Converter - 2. KardioScreen device - 3. KardioScreen application running on Android tablet The device is supplied with patient cables with lead wires that connect to any commercially available disposable ECG electrode. Optional reusable clamp electrodes can be used for the limb leads and bulb electrodes for the chest leads. Once the electrodes have been connected to the patient, the ECG cable with KardioScreen Converter is then connected to the "ECG" port on the KardioScreen device. This module receives the electrical ECG signals, performs processing on the signals and then wirelessly transmits the ECG data through a Bluetooth Low Energy (BLE) interface to a mobile application running on an Android tablet. The ECG waveforms are displayed on the KardioScreen application for viewing and analysis. From the Android tablet, the ECG report can be printed or exported for external use.
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