Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and Primary Care Diagnostics,The Voluson Expert 22, 20, and 18 are advanced ultrasound imaging systems designed for various clinical applications such as OB/GYN, abdominal, cardiac, and musculoskeletal imaging. They offer high-performance real-time 3D/4D imaging, Doppler modes, elastography, and incorporate AI software tools to assist clinicians in image analysis and workflow improvement, helping improve diagnostic accuracy and efficiency in hospitals and medical clinics.
Intended Use
General purpose ultrasound system intended for use by qualified and trained healthcare professionals with clinical applications in fetal/OB, abdominal (including GYN and pelvic), pediatric, small organ, neonatal and adult cephalic, cardiac, musculoskeletal, vascular, transvaginal and transrectal imaging.
Technology
Full-featured Track 3 ultrasound system with mobile console, touch panel, and color display. It uses various linear, curved, matrix phased array transducers for real-time 3D/4D imaging, Doppler modes, elastography, shear wave elastography, and supports DICOM networking. Includes AI software features SonoPelvicFloor, SonoLyst, Shadow Reduction, and Sono FHR for workflow and image performance improvements.
Performance
The device underwent extensive non-clinical testing including acoustic output, biocompatibility, electrical and mechanical safety, and conforming to international standards. AI features were tested on large datasets showing accuracy above 70% for pelvic floor alignment, above 80% for image sorting and grading, and above 70-80% for fetal heart view detection. Independent clinical testing was not required to demonstrate substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/8/2022
3 months - 2
FDA Approval
6/6/2022
Other devices from GE Medical Systems Ultrasound and Primary Care Diagnostics,
- Vivid Pioneer2025 • 510K
- Versana Premier; Versana Premier Lotus; LOGIQ F2024 • 510K
- Voluson Signature 20, Voluson Signature 182024 • 510K
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