FDA Radiology AI Devices

Venue Fit is a compact, portable diagnostic ultrasound system designed for use by trained healthcare professionals. It provides high-quality ultrasound imaging and fluid flow analysis across multiple clinical applications. The system supports standard ultrasound modes and includes AI-assisted features such as nerve tracking to help clinicians during procedures. Venue Fit enhances imaging capabilities and workflow efficiency in hospital and clinical settings.

Venue Go is a portable, general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals to image and analyze the human body and fluid flow. It supports a wide range of clinical applications including abdominal, cardiac, vascular, musculoskeletal, and more. It offers advanced imaging modes and AI-enhanced tools such as cNerve for nerve tracking, aiding clinicians during procedures like nerve blocks. This device helps clinicians obtain high-quality ultrasound images and analyze them efficiently to improve patient care.

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.

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound machines designed to capture and display ultrasound imaging including B-mode, Doppler modes, 3D/4D imaging, and provide measurement and analysis tools to assist healthcare professionals in diagnosing various conditions. They support a wide range of clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more, helping clinicians in hospitals and clinics perform accurate diagnostic imaging and fluid analysis efficiently.

The Aplio a550, a450, and a Diagnostic Ultrasound Systems from Canon Medical Systems Corporation provide high-quality ultrasound images in various modes including 2D, Doppler, Color Doppler, Elastography, and 3D/4D imaging. These systems support advanced features enhanced by artificial intelligence and machine learning to assist clinicians in diagnostics across multiple clinical applications such as fetal, abdominal, cardiac, vascular, musculoskeletal, and more.

The Voluson P6 and Voluson P8 are general-purpose diagnostic ultrasound systems designed for use by trained healthcare professionals. These systems support a variety of clinical applications, including fetal/obstetrics, abdominal, cardiac, pediatric, vascular, musculoskeletal, and small organ imaging. They provide high-quality real-time imaging, including 3D/4D modes, and Doppler imaging types, aiding clinicians in the diagnosis and monitoring of patients in hospital or clinical settings.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 by Canon Medical Systems Corporation, is a high-quality diagnostic ultrasound system that provides detailed visualization of structures and dynamic processes in the human body. It supports multiple ultrasound modes and is suitable for use in hospitals and clinical settings, aiding clinicians in diagnosing conditions across areas including fetal, abdominal, cardiac, musculoskeletal, vascular, breast, and more.

The Voluson S Series (including S6, S8, S8t, S10, and S10 Expert) by GE Healthcare is a general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It provides high-performance ultrasound imaging and analysis with a focus on real-time 3D/4D acquisition across multiple clinical applications such as obstetrics, abdominal, cardiac, vascular, and musculoskeletal imaging. The system supports a variety of probes and modes including Doppler imaging, elastography, and contrast imaging, helping clinicians visualize and measure various body tissues and fluids in a hospital or clinical setting.

The TEX20 and TEX10 series Diagnostic Ultrasound Systems by Shenzhen Mindray are versatile, software-controlled ultrasound machines designed for imaging adults, pregnant women, pediatric patients, and neonates. They support multiple imaging modes such as B-mode, Doppler (including Color, Power, Pulsed Wave), 3D imaging, elastography, and contrast imaging, helping clinicians visualize and measure anatomical structures and blood flow across a wide range of body areas including ophthalmic, fetal, abdominal, cardiac, and musculoskeletal exams. These systems enhance diagnostic confidence and efficiency for healthcare providers through advanced imaging features and AI-assisted tools such as Smart Nerve, which assists in visualizing nerve plexuses for guidance.