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Intended Use

The system is indicated for visualization of structures and dynamic processes within the human body using ultrasound, providing image information for diagnosis across multiple clinical applications including fetal, abdominal, intra-operative, pediatric, small organs, cardiac, peripheral vascular, musculoskeletal, laparoscopic, and thoracic/pleural areas.

Technology

The device is a mobile diagnostic ultrasound system employing a wide range of probes (flat linear array, convex, sector array) with frequencies from 2 MHz to 30 MHz. It supports various high-quality ultrasound imaging modes including B mode, M mode, Continuous Wave, Color Doppler, Pulsed Wave Doppler, Power Doppler, Combination Doppler, Speckle-tracking, Tissue Harmonic Imaging, Shear wave elastography, Elastography, and Acoustic attenuation mapping. Software features include AI-supported functions such as automated initial contour tracing for left ventricle wall motion tracking and auto ejection fraction calculation, as well as advanced image transfer and network storage capabilities.

Performance

The device underwent risk analysis, verification, and validation activities including bench testing with phantoms, test data, and volunteer data to demonstrate that new and improved features meet established specifications and perform as intended. No clinical studies were required to demonstrate safety and efficacy. The device complies with applicable IEC standards and FDA guidance documents for ultrasound system marketing clearance and software content, including cybersecurity considerations.

View FDA documentation

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    7/27/2021

    6 months
  • 2

    FDA Approval

    1/24/2022

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