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510(k) Data Aggregation

    K Number
    K172182
    Device Name
    QUANTIEN Measurement System
    Manufacturer
    St. Jude Medical (now part of the Abbott Medical)
    Date Cleared
    2017-08-18

    (30 days)

    Product Code
    DQK, DOK, DSK
    Regulation Number
    870.1425
    Why did this record match?
    Applicant Name (Manufacturer) :

    St. Jude Medical (now part of the Abbott Medical)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OUANTIEN Measurement System is indicated to provide hemodynamic information for use in the diagnosis and treatment of coronary or peripheral artery disease. QUANTIEN Measurement System is intended for use in catheterization and related cardiovascular specialty laboratories to compute, and display various physiological parameters based on the output from one or more electrodes, transducers, or measuring devices.
    Device Description
    The QUANTIENT™ Measurement System is a diagnostic computer designed to record, compute, display and store data from PressureWire™ guidewire and other external transducers. The information is displayed as graphs as well as numerical values on the screen. Data includes, but is not limited to: systolic, diastolic and mean blood pressure, heart rate, Fractional Flow Reserve (FFR), Pd/Pa, and data from ECG. Fractional Flow Reserve (FFR) is the ratio of distal coronary arterial pressure to aortic pressure, measured during hyperemia. It provides the maximal blood flow in the presence of a stenosis as a fraction of the achievable blood flow that would exist in the hypothetical situation that the stenosis was not present. The physician may use the FFR parameter, along with knowledge of patient history, medical expertise and clinical judgment to determine if therapeutic intervention is indicated. This functionality is achieved when the QUANTIENT™ Measurement System is used in conjunction with the manufacturer's distal intracoronary pressure transducer and a proximal aortic pressure transducer. Pd/Pa is the ratio of distal coronary arterial pressure to aortic pressure measured at resting conditions. The physician may use Pd/Pa at rest, along with knowledge of patient history, medical expertise and clinical judgment to determine if additional measurement of FFR during hyperemia or therapeutic intervention is indicated. Information on screen can also be transferred to an external hemodynamic recording system (HRS) or to an external video monitor. Recorded procedures can be viewed on a PC for post-procedural review and analysis with application specific viewing software installed, such as RadiView™ software. Additional functions let you import a patient work list from the hospital DICOM system, export recorded measurement data to DICOM or to an external server location or save it to a USB memory stick.
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