FDA Radiology AI Devices

cvi42 Software Application is a medical imaging software developed by Circle Cardiovascular Imaging Inc. that supports clinicians by enabling viewing, post-processing, and quantitative analysis of cardiovascular magnetic resonance (MR) and computed tomography (CT) images. It uses semi-automated machine learning algorithms to assist in measuring cardiac function, vessel characteristics, and calcified plaques, helping medical professionals in diagnostic decision-making related to heart and adjacent vessels.

VINT is a software tool designed to assist clinicians in viewing, processing, and quantitatively evaluating cerebrovascular MRI images. It imports DICOM-formatted MR images and analyzes blood flow characteristics of cerebral arteries, including providing signal intensity gradient metrics from TOF-MRA scans. It supports advanced image corrections and data visualization, aiding radiologists in assessing cerebral artery health without the need for contrast medium.

The HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a versatile ultrasound imaging system used by healthcare professionals to obtain and analyze ultrasound images and body fluids. It offers multiple imaging modes including 2D, Color Doppler, Power Doppler, M mode, Pulsed and Continuous Wave Doppler, Tissue Doppler Imaging, and advanced AI-based features such as BiometryAssist, HeartAssist, ViewAssist, and others to aid in image recognition, measurement, and workflow efficiency. It is intended for clinical use in various applications including fetal, abdominal, cardiac, musculoskeletal, and more.

X Sensor is a digital intraoral dental x-ray sensor that captures x-ray photons and instantly converts them to digital images for dentists to view and analyze. It enhances dental diagnostic workflows by providing faster image acquisition with high resolution and image quality, making diagnosis more efficient and reliable.

The syngo Application Software is a medical imaging software developed by Siemens that enables real-time viewing, manipulation, 3D visualization, communication, and postprocessing of medical images. It supports diagnostic review and image-guided interventional procedures across multiple imaging modalities and clinical applications, improving workflow and aiding clinicians in diagnosis and treatment planning.

AutoChamber is an AI-powered software tool designed to analyze both non-contrast and contrast-enhanced chest CT scans to automatically measure and report volumes of cardiac chambers including left atrium, left ventricle, right atrium, right ventricle, and left ventricular wall. It assists healthcare providers by providing quantitative imaging data that helps identify conditions such as enlarged heart and left ventricular hypertrophy, thus aiding in further clinical evaluation and management of cardiovascular risk.

EchoMeasure by iCardio.ai is an AI-powered software that analyzes previously acquired cardiac ultrasound images to automatically measure key cardiac anatomical parameters. It assists cardiologists and healthcare professionals by providing accurate measurements for clinical decision-making, enhancing efficiency and supporting diagnostic review.

The uDR 380i Pro from Shanghai United Imaging Healthcare Co.,Ltd. is a mobile digital radiography system that captures X-ray images of human anatomy for medical diagnosis. Designed for use on both adult and pediatric patients, it is especially useful for patients who cannot be moved to a traditional radiology room. The system includes flat panel detectors, a high-power generator, and a maneuverable design, enabling clinicians to obtain high-quality diagnostic images at the point of care.

Limbus Contour is a software tool designed to help medical professionals automatically create accurate contours of healthy anatomical structures from CT and MRI images. These contours are used to plan and evaluate radiation treatment for cancer patients, improving efficiency and consistency in treatment preparation.

The EPIQ Series Diagnostic Ultrasound System by Philips is an advanced ultrasound imaging device that uses AI-powered software to aid clinicians in semi-automated quantification of heart valve function, specifically assessing the tricuspid valve and mitral valve regurgitation. This helps improve accuracy and efficiency in diagnosing cardiac conditions by providing detailed measurements and flow analysis from 3D ultrasound images.