Voluson™ Performance 16; Voluson™ Performance 18
GE Medical Systems Ultrasound and Primary care DiagnosticsThe Voluson™ Performance 16 and Voluson™ Performance 18 are advanced diagnostic ultrasound systems designed for use by trained healthcare professionals to image, measure, display, and analyze human body structures and fluids. These systems support a wide range of clinical applications including fetal/obstetrics, abdominal, pediatric, small organ, cardiac, vascular, musculoskeletal, and more. They provide real-time 3D/4D imaging, various Doppler modes, elastography, and have integrated AI features to assist in analysis. These systems enhance clinicians' ability to perform ultrasound examinations efficiently and with high image quality, aiding patient diagnosis and care.
Intended Use
Voluson™ Performance 16 / Voluson™ Performance 18 are general-purpose diagnostic ultrasound systems intended for use by qualified and trained healthcare professionals legally authorized or licensed to perform ultrasound imaging, measurement, display, and analysis of the human body and fluid in diverse clinical applications including fetal/obstetrics, abdominal, pediatric, cardiac, vascular, musculoskeletal, and more.
Technology
The systems are full-featured ultrasound imaging devices with mobile consoles, color LCD/TFT touch panels, multiple advanced ultrasound acquisition modes including real-time 3D/4D, Doppler, elastography, and contrast imaging. They utilize a variety of mechanical and electronic scanning transducers providing accurate real-time three-dimensional imaging and comprehensive networking and DICOM capabilities.
Performance
The device conforms to multiple recognized safety and performance standards, including electrical safety, biocompatibility, electromagnetic compatibility, ultrasound-specific safety, and DICOM standards. It underwent extensive quality assurance processes including risk analysis, design reviews, and verification testing. Clinical studies were not required to support substantial equivalence, with testing demonstrating the device performs as safe and effective as predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/24/2025
3 months - 2
FDA Approval
5/29/2025
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
Ready to Sharpen Your Edge?
Join hundreds of your peers who rely on RadAI Slice. Get the essential weekly briefing that empowers you to navigate the future of radiology.
We respect your privacy. Unsubscribe at any time.