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510(k) Data Aggregation

    K Number
    K213279
    Device Name
    NovaGuide 2 Intelligent Ultrasound
    Date Cleared
    2022-03-02

    (152 days)

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

    NovaSignal Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    NovaGuide 2 Intelligent Ultrasound is a medical ultrasound system intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. The system assists the user in the setup and acquisition of cerebral blood flow velocity via the patient's temporal windows. NovaGuide 2 Intelligent Ultrasound is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field.
    Device Description
    NovaGuide 2 is a mobile, non-invasive, non-ionizing radiation transcranial Doppler (TCD) ultrasound system. It is intended for use as an adjunct to standard clinical practices for measuring and displaying cerebral blood flow velocity and the occurrence of transient emboli within the bloodstream. NovaGuide 2 is intended to be used by healthcare professionals qualified by training in its safe and effective use. The device is not intended to replace other means of evaluating vital patient physiological processes, is not intended to be used in fetal applications, and is not intended to be used inside the sterile field. NovaGuide 2 is a cart-mounted system for use in hospitals or clinics. The system is comprised of a computer, Doppler Robotics Unit (DRU), probe pods, patient headmount unit (PHU) and two reusable, non-sterile 2-MHz transducers that can be operated in either robotic or manual modes. When used in robotic mode, the operator is guided in positioning the two transducers, one on each side of the patient's head. The transducers are positioned using robotic actuators that adjust the translational and angular positions using TCD signal search algorithms, which assists the operator in monitoring the blood flow velocity of the vessels via the patient's temporal acoustic windows. Visualization and detection of emboli occur through High-Intensity Transient Signals (HITS) in the display of the TCD blood flow.
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