FDA Radiology AI Devices

The SonoVision Ultrasound Imaging System is a general-purpose ultrasound device designed to help physicians visualize nerves, vascular structures, and other anatomical features, especially during spinal procedures. It uses a specialized ultrasound probe and advanced image processing software to provide real-time imaging assistance, enhancing the accuracy and safety of medical interventions.

Caption Guidance is an AI software accessory for ultrasound systems that helps clinicians, including those without specialized training, acquire high-quality cardiac ultrasound images. It provides real-time feedback and prescriptive guidance to optimize the capture of diagnostic standard 2D echocardiographic views, supporting quicker and more reliable heart assessments.

QLAB Advanced Quantification Software is a tool designed to help clinicians view and measure ultrasound images, specifically focusing on analyzing the heart's right ventricle using advanced automatic segmentation and machine learning. It assists healthcare professionals by providing accurate measurements that improve cardiac assessments without manual contouring for most cases, making the diagnostic process faster and more reliable.

EchoGo Core is an automated software application that processes echocardiogram images to measure cardiac function parameters such as ejection fraction, global longitudinal strain, and left ventricular volumes. It provides clinicians with quantitative reports to assist in diagnosing heart conditions, improving accuracy and reducing variability compared to manual methods.

The Ventripoint Medical System Plus (VMS+) 3.0 is a software and hardware system that works as an adjunct to ultrasound imaging. It records and analyzes 2D ultrasound images to reconstruct a 3D model of the heart's four chambers, helping clinicians measure heart chamber volumes and ejection fractions. This aids in cardiac assessment by providing detailed and accurate cardiac volume measurements using advanced image analysis techniques.

The Clarius Ultrasound Scanner is a portable, software-controlled ultrasound system that connects wirelessly to iOS or Android devices to provide high-resolution, real-time diagnostic ultrasound and Doppler imaging. It supports multiple clinical applications such as abdominal, cardiac, musculoskeletal, fetal, and procedural guidance, helping clinicians perform ultrasound imaging conveniently in diverse healthcare settings.

Koios DS for Breast is a machine learning-based software that assists physicians in analyzing ultrasound images of breast lesions. It helps classify breast lesions into BI-RADS categories to support diagnostic accuracy, improve consistency between readers, and provide useful visual confidence indicators. The software processes selected regions of interest on ultrasound images and provides diagnostic support to clinicians.

AmCAD-UO is a software application designed to analyze ultrasound images of the upper airway. It helps physicians visualize and quantify airway size, position, and tissue characteristics to monitor airway conditions more effectively. It supports manual and interactive region selection for detailed analysis and is intended to assist clinical evaluation, not to be used as a sole diagnostic tool.

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.

The Uscan by EchoNous, Inc. is a handheld diagnostic ultrasound system designed for non-invasive imaging of the human body, including abdominal, musculoskeletal, pediatric, small organ, and peripheral vessel imaging. It also features automated bladder volume measurement, assisting clinicians in quickly and accurately assessing patients without invasive procedures.