Voluson Expert 22, Voluson Expert 20, Voluson Expert 18
Description
The systems are full-featured Track 3 ultrasound systems, primarily for general radiology use and specialized for OB/GYN with particular features for real-time 3D/4D acquisition. They consist of a mobile console with keyboard control panel; color LCD/TFT touch panel, color video display and optional image storage and printing devices. They provide high performance ultrasound imaging and analysis and have comprehensive networking and DICOM capability. They utilize a variety of linear, curved linear, matrix phased array transducers including mechanical and electronic scanning transducers, which provide highly accurate real-time three-dimensional imaging supporting all standard acquisition modes. https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices The systems are all intended for diagnostic ultrasound imaging and fluid flow analysis.
Detailed example
Recommended image contours.
AI / analytics pattern
Computer Vision: AI that processes and interprets visual data (e.g., images and videos).
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Accelerate ultrasound workflows.
Controls / human review
ATO: Not reported; PIA: Not published