FDA Radiology AI Devices

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.

EchoMD Automated Ejection Fraction Software by Bay Labs, Inc. is an AI-powered tool that analyzes previously acquired cardiac ultrasound images to automatically calculate the left ventricular ejection fraction, assisting clinicians in cardiac evaluation by providing streamlined, automated measurements integrated with DICOM-compatible PACS systems.

The Clarius Ultrasound Scanner is a portable, wireless ultrasound imaging system designed for diagnostic use across multiple body regions. It connects via Wi-Fi to mobile devices, allowing healthcare professionals to visualize real-time, high-resolution ultrasound images and fluid flow analysis in diverse clinical applications such as fetal, abdominal, cardiac, musculoskeletal, and more. This device facilitates medical imaging in varied clinical environments by enabling image acquisition on tablets and smartphones.

The Ventripoint Medical System Plus (VMS+) is an advanced ultrasound image analysis device that works alongside existing ultrasound systems. It digitally records and processes 3D ultrasound images to help clinicians evaluate the volumes and functions of the heart's left and right ventricles as well as the left and right atria. This aids in detailed cardiac assessment, providing valuable information on heart chamber sizes and function, which supports diagnosis and management of cardiac conditions.

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.

The BladderScan Prime PLUS System is a non-invasive ultrasound device that measures the volume of urine in the bladder using patented neural network technology. It assists clinicians by providing real-time bladder volume measurements and directional aiming feedback to improve patient management and care.