Voluson Expert 18; Voluson Expert 20; Voluson Expert 22
GE Medical Systems Ultrasound and Primary care DiagnosticsThe Voluson Expert Series (including models 18, 20, and 22) by GE Healthcare is a range of advanced ultrasound imaging systems designed for use by trained healthcare professionals in hospitals and clinics. They provide high-performance real-time ultrasound imaging and analysis capabilities including 2D, 3D, 4D, color Doppler, power Doppler, pulse wave Doppler, harmonic imaging, elastography, and advanced AI-assisted software for obstetric and gynecologic assessments. This helps clinicians obtain detailed diagnostic images for fetal, abdominal, cardiac, musculoskeletal, and other clinical applications, supporting accurate diagnosis and patient care.
Intended Use
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals. Specific clinical applications remain the same as previously cleared: Fetal/OB; Abdominal (including GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional and Superficial; Vascular; Transvaginal (including GYN); Transrectal. Modes of operation include B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, Shear Wave Elastography and Combined modes.
Technology
The systems are mobile ultrasound consoles with keyboard control panels and color video displays featuring high performance ultrasound imaging and analysis, comprehensive networking and DICOM capabilities. They employ a variety of linear, curved linear, and matrix phased array transducers providing real-time 3D/4D imaging and support all standard acquisition modes, including Doppler, elastography, and harmonic imaging. Additional AI software features include SonoLyst for pelvic floor and trimester assessment, O-RADS for ovarian adnexal reporting, and automated follicle volume counts.
Performance
The device underwent extensive non-clinical testing including acoustic output, biocompatibility, cleaning and disinfection, safety standards compliance (IEC 60601, ISO10993, ISO14971). AI software features were validated with clinical data from multiple sites and countries, showing high success rates and accuracy in segmentation and classification tasks (e.g., SonoLyst, SonoAVC follicle, pelvic floor). Clinical studies were not required for this submission as it was substantially equivalent to previous predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/24/2024
4 months - 2
FDA Approval
12/20/2024
Other devices from GE Medical Systems Ultrasound and Primary care Diagnostics
- Venue; Venue Go; Venue Fit; Venue Sprint2025 • 510K
- EchoPAC Software Only / EchoPAC Plug-in2025 • 510K
- Vivid Pioneer2025 • 510K
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