Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
GE Medical Systems Ultrasound and Primary Care Diagnostics,The Voluson Expert series (including models 22, 20, and 18) is a general-purpose ultrasound system designed for use by trained medical professionals. It supports a wide range of clinical applications including obstetrics/gynecology, abdominal, cardiac, pediatric, musculoskeletal, vascular, and more. The system offers multiple imaging modes such as B-mode, Doppler modes, 3D/4D imaging, elastography, and advanced AI features like SonoPelvicFloor2.0, SonoAVC2.0, Fibroid Mapping, Blood Speckle Imaging, and Ophthalmic Artery Measurement. These AI features assist clinicians by automating tasks such as organ and lesion segmentation, improving workflow efficiency and diagnostic confidence. It is intended for use in hospitals or clinics and complies with medical device safety standards.
Intended Use
The device is a general purpose ultrasound system intended for use by qualified and trained healthcare professionals for a variety of clinical applications such as fetal/OB; abdominal including GYN, pelvic, infertility monitoring/follicle development; pediatric; small organ (breast, testes, thyroid); neonatal and adult cephalic; cardiac (adult and pediatric); musculoskeletal conventional and superficial; vascular; transvaginal (including GYN); and transrectal imaging.
Technology
The Voluson Expert Series employs ultrasonic pulsed Doppler and echo imaging technologies, with a mobile console equipped with advanced transducers including linear, curved linear, and matrix phased arrays providing real-time 3D/4D imaging modes, Doppler modes, as well as elastography techniques. It integrates AI-driven software features such as SonoPelvicFloor2.0, SonoAVC2.0, Fibroid Mapping, Blood Speckle Imaging, and Ophthalmic Artery Measurement to automate and enhance diagnostic workflows.
Performance
The device underwent verification including AI feature testing for SonoPelvicFloor2.0, Fibroid Mapping, and SonoLyst features using multi-site data collected across different systems and probes. The AI showed high accuracy on image quality datasets and good generalizability tested on unseen data distribution. Safety and performance evaluations include acoustic output, biocompatibility, cleaning, and conformity to electrical and mechanical safety standards. Clinical studies were not required for this submission.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/3/2023
3 months - 2
FDA Approval
10/30/2023
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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