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510(k) Data Aggregation

    K Number
    K192253
    Device Name
    SonicEye Dual-Array Ultrasound System
    Date Cleared
    2020-02-25

    (189 days)

    Product Code
    Regulation Number
    892.1560
    Why did this record match?
    Applicant Name (Manufacturer) :

    Sonivate Medical Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SonicEye® Dual-Array Ultrasound System is for use in B-mode (grayscale) imaging of human subjects in the following clinical applications: Fetal, Cardiac (adult and pediatric, Abdominal, Pediatric, Peripheral vessel, Musculoskeletal (conventional and superficial), Small parts (breast, thyroid, testes), Thoracic/pleural. The device is intended for use by medical professionals to include doctors, imaging technicians, emergency medicine and military corpsmen/medics that have been trained in basic sonography techniques. The use would include medical environments such as hospitals, clinics, military field aid stations.
    Device Description
    The SonicEye® Dual-Array Ultrasound System is a lightweight, battery-powered unit that contains an innovative dual-array fingertip transducer which incorporates two transducer arrays, a high-frequency linear and a low-frequency phased, in a single easily-controlled fingertip design that can be worn on the fingertip or held between the thumb and forefinger like most ultrasound probes. The transducer is hard-wired to an image processor module that is firmware controlled. The image processor controls the behavior of the device including; beamforming, image construction, and power management; and transmits acquired data via USB cable to a computer tablet, with proprietary SonicEye Application software installed. The Windows application allow the operator to view scanned images and to control the user-selectable features of the device. The system operates in B-Mode ONLY.
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