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510(k) Data Aggregation

    K Number
    K143094
    Device Name
    QuantaFlo
    Manufacturer
    SEMLER SCIENTIFIC, INC.
    Date Cleared
    2015-03-05

    (128 days)

    Product Code
    JOM
    Regulation Number
    870.2780
    Why did this record match?
    Applicant Name (Manufacturer) :

    SEMLER SCIENTIFIC, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    QuantaFlo is intended to aid clinicians in the diagnosis and monitoring of Peripheral Arterial Disease. It provides bilateral, non-invasive physiologic studies of the upper and lower extremity arteries, using volume plethysmography of the posterior tibial and anterior tibial/dorsalis pedis arterial distributions. Additionally, QuantaFlo may be used to perform bilateral, non-invasive physiologic studies of the upper and lower extremity arteries with provocative functional maneuvers. The device is for adult use and not for pediatric or fetal use.
    Device Description
    QuantaFlo aids clinicians in the diagnosis of vascular disease by measuring blood volume changes using volume plethysmography in the Brachial, Posterior Tibial, and Anterior Tibial/Dorsal Pedis arterial distributions. From these signals it calculates a result that is predictive of Peripheral Arterial Disease (PAD). In addition. QuantaFlo provides hard-copy waveforms as part of the report, which may be viewed on the system display, printed, and/or saved. The clinician places a sensor and makes a measurement on each upper extremity and each lower extremity. The sensor includes a transducer, which detects changes in arterial blood volume. This signal is digitized and sent to a computer, which runs a specifically-designed software application. The application calculates the result via a proprietary algorithm, which is based on the features of the volume plethysmography signals from the Brachial. Anterior Tibial / Dorsalis Pedis, and Posterior Tibial arterial distributions.
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