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510(k) Data Aggregation

    K Number
    K141462
    Device Name
    VARIA-NCI
    Date Cleared
    2014-11-19

    (169 days)

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

    NEUROCHAOS SOLUTIONS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Varia-NCI is a stand-alone software accessory to a Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, and displays Cerebral Blood Flow velocity (CBFv) data from a Transcranial Doppler Ultrasound device. Varia-NCI uses CBFv data to measure the variability of a patient's cerebral blood flow velocity. Varia-NCI is to be used by clinicians managing head trauma in the ICU, Surgical Unit, Emergency Department, and Clinical and Sports Medicine Settings.
    Device Description
    Varia-NCI is a stand-alone software accessory to a Transcranial Doppler Ultrasound device (TCD) that retrieves, analyzes, stores, and displays Cerebral Blood Flow velocity (CBFv) data from a Transcranial Doppler Ultrasound device. Varia-NCI uses CBFv data to measure the variability of a patient's cerebral blood flow velocity. Varia-NCI accesses data from Compumedics Germany QL 3.0 software. QL 3.0 is a trade mark of PC-based software supplied by Compumedics Germany, GmbH and included with their digital Transcranial Doppler (TCD) Ultrasound device.
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