FDA Radiology AI Devices

AVA (Augmented Vascular Analysis) by See-Mode Technologies is a software that uses artificial intelligence to analyze vascular ultrasound images from carotid and lower limb arteries. It segments vessel walls, measures carotid intima-media thickness, reads Doppler velocities, and generates detailed vascular ultrasound reports to aid clinicians like physicians and medical technicians in assessing cardiovascular health. The software runs on standard computers or cloud platforms and supports quality control by qualified clinicians to ensure accuracy.

The Vivid iq is a high-performance compact diagnostic ultrasound system made by GE Medical Systems Ultrasound. It supports a wide range of clinical applications including cardiovascular, abdominal, fetal, musculoskeletal, and more. The system enables automatic AI-based cardiac measurements and spectrum recognition to assist clinicians in analysis and diagnosis. It is intended for use by trained healthcare professionals in hospitals and private medical offices.

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.

SIGNA Artist is a magnetic resonance imaging (MRI) scanner designed to produce high-resolution diagnostic images of the whole body. It supports multiple imaging planes and can generate a variety of images including axial, sagittal, coronal, spectroscopic, parametric maps, and dynamic images. The AIR Recon DL software feature enhances image quality by improving signal-to-noise ratio and sharpness, assisting clinicians in diagnosis through clearer MRI images.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to detect incidental pulmonary embolism. The software notifies radiologists of suspected positive cases via a desktop application, helping prioritize urgent cases for faster review without replacing the standard diagnostic process. It supports workflow improvements by flagging cases early, potentially saving hours in time to examination.

AVIEW by Coreline Soft is a comprehensive medical imaging software that processes CT images of the lungs and heart. It helps physicians analyze lung tissue quantitatively, characterize lung nodules, evaluate coronary artery calcium, and monitor progression of lung disease. The software provides advanced segmentation, registration, quantitative metrics, and reporting tools, integrating AI techniques such as deep learning and CAD to enhance diagnostic support and workflow efficiency.

TOMTEC-ARENA is a clinical software package designed for reviewing, quantifying, and reporting medical imaging data primarily related to cardiovascular, fetal, and abdominal structures. It helps clinicians assess structures and functions from various imaging modalities in multiple dimensions, facilitating disease diagnosis through detailed quantifications and advanced visualization tools.

Limbus Contour is a software tool that uses machine learning to automatically create contours of normal anatomical structures on CT and MRI images for use in radiation therapy planning. It helps trained clinicians by providing optimized contours that can be imported into treatment planning systems, improving efficiency and accuracy in defining healthy tissues.

Syngo.via RT Image Suite is a medical imaging software tool that helps clinicians visualize and manipulate 3D and 4D images from multiple modalities like CT, PET, and MRI in preparation for radiation therapy treatments. It provides advanced contouring tools including AI-based automatic organ segmentation, multi-modality image fusion, and supports creating treatment plans to improve accuracy and efficiency in radiation therapy workflows.

AccipioIx is an AI-based software that processes non-contrast head CT scans to identify signs of acute intracranial hemorrhage. It helps clinicians prioritize urgent cases for faster review by analyzing images and flagging suspected hemorrhages, improving workflow efficiency in acute care settings.