Versana Balance
GE Medical Systems Ultrasound and Primary Care Diagnostics,The Versana Balance by GE Medical Systems is a general-purpose diagnostic ultrasound system intended for use by trained healthcare professionals. It offers various imaging modes including B-mode, Doppler, 3D/4D imaging, and elastography. The device assists clinicians by providing high-quality ultrasound images and includes AI features such as Whizz Label for anatomy identification, helping in image interpretation and workflow efficiency. It is designed for use in hospitals and clinics across a broad range of clinical applications including abdominal, cardiac, obstetrics, gynecology, vascular and musculoskeletal imaging.
Intended Use
The Versana Balance is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid across multiple clinical applications.
Technology
The device is a mobile diagnostic ultrasound system with digital acquisition, processing, and display capabilities. It includes a console with control panel, multiple transducer types (convex, linear, sector, 4D), and supports many operation modes including B, M, Doppler, Color Doppler, harmonic imaging, elastography, and 3D/4D imaging. It incorporates AI-based features such as Whizz Label (anatomy identification) and Whizz Color Flow (automatic color flow optimization). It supports connectivity options including DVD, USB, LAN, WiFi, and Bluetooth.
Performance
The device underwent evaluation for acoustic output, biocompatibility, safety (thermal, electrical, electromagnetic, mechanical), cleaning, and disinfection effectiveness, complying with applicable standards such as IEC 60601 series and ISO 10993-1. No clinical studies were required to support substantial equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
2/16/2022
2 months - 2
FDA Approval
5/11/2022
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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