Intended Use

The multifunctional ultrasound scanner is used to collect, display and analyze ultrasound images during ultrasound imaging procedures in combination with supported echographic probes.

Technology

The system consists of a control panel assembly with LCD monitor and device electronics enclosed in an ergonomic cart, uses physical ultrasound properties (sound waves above 20 kHz) to image deep tissues by recording echoes, operates with various ultrasound modes including B-Mode, M-Mode, Doppler (Pulsed and Continuous Wave), Color Flow Mapping, Power Doppler, Tissue Velocity Mapping, combined modes, Elastosonography, 3D/4D, and Contrast imaging (CnTI). It also features wireless capability and supports various probe types (Phased Array, Convex, Linear, Doppler, Volumetric).

Performance

Performance testing included acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety testing. AI features (AutoOB and AutoCM) were validated using statistically rigorous acceptance criteria showing high success rates in biometric measurement tasks with training and test datasets. No clinical studies were required for substantial equivalence.

Predicate Devices

No predicate devices specified

Device Timeline

  • 1

    Submission

    10/15/2024

    8 months
  • 2

    FDA Approval

    6/18/2025

Other devices from Esaote S.p.A.

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