FDA Radiology AI Devices

The Resona A10S and related series are advanced diagnostic ultrasound systems used by healthcare professionals to acquire, display, and analyze ultrasound images and measurements of the human body. The system supports a wide range of ultrasound imaging modes and can be used in diverse clinical applications such as cardiac, abdominal, gynecologic, and musculoskeletal exams, thus aiding clinicians in diagnosis and patient care.

ProFound Detection V4.0 is an AI-powered software designed to assist radiologists by detecting suspicious soft tissue densities and calcifications in 3D digital breast tomosynthesis (DBT) images. It helps identify potential malignant lesions by marking findings and providing confidence scores, thus supporting earlier and more accurate breast cancer detection during image interpretation.

Hybrid Viewer is a software application used in nuclear medicine and radiology that processes and analyzes imaging data to help clinicians assess physiological or pathological states. It supports predefined workflows optimized for specific nuclear medicine studies and allows quantitative analysis to assist clinical management, though it does not replace visual assessment.

The IODR1717 / IODR1417 / IODR1417-GF detectors are digital flat panel X-ray detectors designed for high-quality digital radiography in general anatomical imaging for adults and children. They replace film-based systems and facilitate faster, streamlined digital radiography with wireless or wired connectivity, enhancing image acquisition and processing for clinicians.

icobrain aria is a software tool that helps radiologists detect and assess amyloid-related abnormalities in brain MRI scans of Alzheimer's disease patients undergoing antibody treatment. It uses AI to highlight and measure edema and microhemorrhages, aiding in clinical decisions and monitoring disease progression safely and effectively.

NeuroICH is a software tool designed to analyze non-contrast CT scans of the head using artificial intelligence to detect signs of intracranial hemorrhage. It provides notifications to specialist clinicians via a mobile app, helping to prioritize patient care without replacing standard diagnostic procedures.

TeraRecon Cardiac.Chambers.MR is a software tool designed to automatically segment the anatomical structures of cardiac chambers from contrast or non-contrast cardiac MR scans in adult patients. It helps clinicians by providing precise delineation of the left and right ventricular walls, facilitating faster and more accurate cardiac assessment.

JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.

The uDR 780i is a digital medical X-ray system designed for diagnostic imaging of various anatomical sites, including the skull, spinal column, chest, abdomen, and extremities. It supports examinations for both adult and pediatric patients in multiple positions. This system generates high-quality radiographic images that can be reviewed, stored, and shared via DICOM network, aiding clinicians in accurate and efficient diagnosis.

eRAD PACS is a software-only system that helps medical professionals receive, organize, store, and review medical images and clinical reports from various imaging modalities. It supports hospitals and imaging centers by providing access to diagnostic images and reports via web and custom interfaces, facilitating efficient image management and review for clinicians.