Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
Ge Medical Systems Ultrasound and Primary Care DiagnosticsThe Voluson Expert Series (models 18, 20, and 22) are advanced ultrasound systems designed for use by trained healthcare professionals in hospitals or medical clinics. They offer comprehensive imaging capabilities including 2D, Doppler, 3D/4D, elastography, and shear wave imaging modes. The devices support various clinical applications such as fetal and obstetric imaging, abdominal, cardiac, small organ, pediatric, musculoskeletal, vascular, and gynecology imaging. They incorporate AI features like SonoLyst for assisting in first trimester pregnancy assessments. The systems provide high-quality real-time imaging and analysis, helping clinicians perform accurate diagnoses and patient monitoring.
Intended Use
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals for imaging various body regions including fetal/OB, abdominal, pediatric, small organs, cardiac, musculoskeletal, vascular, transvaginal, and transrectal.
Technology
The system uses linear, curved, matrix phased array, mechanical and electronic scanning transducers providing real-time 3D/4D imaging and multiple Doppler modes. It supports B, M, PW Doppler, CW Doppler, Color Doppler, Harmonic Imaging, elastography and AI-based image analysis like SonoLyst. The hardware is a mobile console with touchscreen and keyboard control panel. It is DICOM-enabled and has comprehensive networking. A variety of transducers, including electronic 4D probes, are supported.
Performance
The AI feature SonoLyst for first trimester fetal assessment was validated with extensive training and testing datasets collected from multiple sites and systems with an average accuracy above 80%. Confounder analysis demonstrated robust performance across different probe types and geographic regions. Non-clinical testing confirmed compliance with electrical, mechanical, acoustic safety and imaging standards. Clinical testing was not required for substantial equivalence.
Predicate Devices
No predicate devices specified
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