FDA Radiology AI Devices

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.

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.

Versana Premier is a general purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It supports multiple clinical applications such as fetal, abdominal, gynecological, cardiac, vascular, musculoskeletal, and more. It includes various advanced imaging modes and features AI-based enhancements like Whizz Label to assist clinicians in acquiring and interpreting ultrasound images efficiently and accurately. The system is intended for hospitals and medical clinics to aid in the diagnosis and assessment of medical conditions.

EchoPAC Software Only / EchoPAC Plug-in is a diagnostic ultrasound image analysis software by GE that enables physicians to view, post-process, measure, and analyze ultrasound images across many clinical applications including cardiac, fetal, abdominal, musculoskeletal, and vascular imaging. It incorporates AI-based features to semi-automate cardiac measurements and streamline image interpretation, helping clinicians obtain quantitative data more efficiently and accurately.

The Vivid T8 and Vivid T9 are advanced ultrasound imaging systems designed primarily for cardiac imaging but also applicable to vascular and general radiology. These systems provide high-quality ultrasound imaging with various transducer options and include AI-based features that assist clinicians by semi-automating measurements and recognizing Doppler spectra. They support multiple clinical applications in hospital and private settings and enhance diagnostic accuracy and efficiency through AI integration.

The Vivid S60N and Vivid S70N are advanced general-purpose ultrasound imaging systems by GE Healthcare, specialized for cardiac imaging but also supporting a broad range of diagnostic ultrasound applications across the human body. These systems facilitate ultrasound imaging, measurement, display, and analysis to assist physicians in clinical environments such as hospitals and private offices, enhancing diagnostic accuracy and workflow efficiency through digital acquisition, processing, and semi-automated AI-based measurement features.

The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also support other applications such as fetal, abdominal, pediatric, vascular, and musculoskeletal imaging. These systems use ultrasound technology to produce detailed real-time images, including 3D and 4D imaging, helping clinicians diagnose and monitor various conditions effectively. The devices also feature enhanced workflow tools, advanced imaging options, and support comprehensive networking and data sharing capabilities, improving the efficiency and accuracy of ultrasound examinations.

Venue is a general-purpose diagnostic ultrasound system designed for use by qualified healthcare professionals in various clinical settings including critical care, emergency rooms, and outpatient offices. It supports multiple ultrasound imaging applications for different body regions, facilitating imaging, measurement, and analysis of human body structures and fluid, thereby aiding clinical diagnosis and interventional procedures.