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510(k) Data Aggregation

    K Number
    K023431
    Device Name
    QUANTIX/ND DEVICE
    Manufacturer
    CARDIOSONIX, LTD.
    Date Cleared
    2002-11-13

    (29 days)

    Product Code
    DPW
    Regulation Number
    870.2100
    Type
    Special
    Panel
    Cardiovascular
    Reference & Predicate Devices
    K013803
    Why did this record match?
    Device Name :

    QUANTIX/ND DEVICE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Quantix/ND device is intended for non-invasive, peripheral vessel examinations of blood flow measurements
    Diagnostic Blood Flow Measurements

    Device Description

    The Quantix/ND is a dual-beam, angle-independent, pulse-wave Doppler ultrasound system used for non-invasive (peripheral vessel) volume blood flow measurements, including blood flow velocity and volume blood flow. In addition to the conventional Doppler (blood flow velocity) measurements, the Quantix/ND technology utilizes special applications of ultrasound Doppler methods to obtain real-time measurements according to the definition of volume blood flow in target blood vessels. By definition, blood flow is the product of velocity and cross-sectional area. In other words, the volume blood flow is calculated by deriving flow velocity from the Doppler shift frequency using the basic standard formula and then multiplying the velocity by the cross-section area of the blood vessel.

    AI/ML Overview

    It is impossible to provide the requested information based on the input text. The provided text is a 510(k) premarket notification for the Quantix/ND Device, which focuses on demonstrating substantial equivalence to a predicate device.

    The document does not contain:

    • Any specific acceptance criteria or performance metrics for the Quantix/ND device.
    • Details of a study proving the device meets acceptance criteria.
    • Information on sample sizes, data provenance, ground truth establishment, or expert qualifications for testing.
    • Any mention of multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance studies.

    The document primarily describes the device, its intended use, and its technological characteristics in comparison to a predicate device (FlowGuard, K013803) to assert substantial equivalence, which is the basis for 510(k) clearance. Clinical performance data or detailed validation studies with defined acceptance criteria are not typically part of the summary provided in a 510(k) notification unless specifically requested or if substantial equivalence cannot be established through other means.

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