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510(k) Data Aggregation

    K Number
    K123565
    Device Name
    PRESTO 1000 SYSTEM
    Manufacturer
    Date Cleared
    2012-12-13

    (23 days)

    Product Code
    Regulation Number
    892.1550
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHYSIOSONICS, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Presto 1000 transcranial Doppler ultrasound system is intended for use in the ICU and surgical suite as an ultrasound fluid flow analysis system for the monitoring of middle cerebral artery blood velocities. Vessels intended for monitoring are solely the M1 segments of the middle cerebral arteries via the temporal windows on the left and right sides of the head. The Presto 1000 calculates cerebrovascular flow index values to identify the presence of hemodynamically significant deviations from normal values. It records changes in these indices over time for later review, displays trends in user selected flow indices, and generates alerts when user selected indices exceed user defined levels, based on physician requirements and patient needs. The device is not intended to replace other means of evaluating vital patient physiological processes, such as pulse oximetry, electroencephalography or electrocardiography, is not intended to be used in fetal applications, and is not intended to be used in the sterile field.
    Device Description
    The Presto 1000 is a color/PW transcranial Doppler (TCD) ultrasound monitor incorporating two permanently connected two-dimensional phased array transducers, to be used in a headset, for long term bilateral monitoring of blood flow in the M1 segment of the middle cerebral artery (MCA), through the temporal windows. Transducers are intended to be used with single use acoustic couples couplers, which increase patient comfort and improve mechanical compliance to maintain acoustic coupling during long term monitoring. Transducers may only be mounted to the headset when fitted with this acoustic coupler.
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