FDA Radiology AI Devices

Hepatica v1 is a software tool used by clinicians to analyze MRI scans of the liver. It processes MRI data to create detailed 3D models of the liver by segments and provides quantitative measurements of liver tissue health such as iron-corrected T1 and fat fraction. This information supports the evaluation of liver volume and health, aiding clinical and surgical decision making for patients.

The Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i is a computed tomography (CT) scanner designed for whole body imaging, including the head. It incorporates an AI-driven image reconstruction algorithm called AiCE-i that reduces image noise and improves image quality by using deep convolutional neural networks. This enhancement supports clinicians by providing clearer, more detailed images with potentially lower radiation dose, facilitating better diagnosis and patient care.

The Imagio Breast Imaging System is a diagnostic tool that combines optoacoustic imaging and ultrasound to provide detailed structural and functional information about breast abnormalities. It uses AI-based software to help healthcare providers better classify breast masses, thereby improving diagnosis. The device is designed to assist, not replace, mammographic screening or biopsy.

HeartFlow Analysis is a medical software that uses previously acquired coronary CT images to create 3D models and simulate blood flow dynamics in coronary arteries. It helps clinicians assess coronary artery disease by providing detailed functional information derived mathematically from CT scans, supporting diagnosis and treatment planning in stable symptomatic patients.

BrainInsight is a software tool designed to analyze low-field MRI brain scans automatically. It uses machine learning to segment brain structures, measure volumes, and provide annotated images and reports to assist clinicians in evaluating brain anatomy quickly and efficiently.

BriefCase is an AI-based software by Aidoc Medical that helps radiologists and trained medical specialists detect and prioritize urgent cases from CT scans of various body regions including head, chest, abdomen, and cervical spine. It flags images with suspected critical findings like fractures, intracranial hemorrhage, pulmonary embolism, intra-abdominal free gas, and large vessel occlusion, presenting low-quality preview images and notifications to accelerate clinical workflow. The software works in parallel with standard of care and does not alter original medical images, serving as a triage and notification aid but not a diagnostic device.

AI Metrics is a software-based medical imaging tool that helps clinicians view, annotate, and analyze images from multiple modalities and time points. It automates workflow steps in assessing diseases and monitoring response to therapy according to standards like RECIST 1.1, supporting clinical interpretations and documentation in radiology and oncology settings. Importantly, it assists but does not replace the physician's diagnosis process.

EchoGo Pro is an AI-powered software tool designed to assist physicians in diagnosing coronary artery disease by analyzing stress echocardiography ultrasound images. It processes images acquired during stress echo exams, automatically segments the left ventricle, and uses machine learning to provide a categorical assessment of the likelihood of significant CAD, helping clinicians make more accurate and consistent diagnoses.

Deep Learning Image Reconstruction for Gemstone Spectral Imaging by GE Medical Systems is an AI-powered CT image reconstruction method designed to produce high-quality cross-sectional CT images from dual-energy X-ray data. It is intended for whole body, vascular, and contrast-enhanced head CT applications, enhancing image quality with a deep neural network-based algorithm that improves low contrast detectability, noise reduction, and artifact suppression, supporting accurate and reliable diagnosis.

The Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i is a whole-body multi-slice helical CT scanner that acquires and displays cross-sectional volume images, including the head. It incorporates AiCE, an AI-based noise reduction algorithm using deep convolutional neural networks, to improve image quality and reduce noise in scans of the abdomen, pelvis, lung, extremities, head, and inner ear. This technology helps clinicians obtain clearer images at potentially lower radiation doses, facilitating better diagnostic accuracy.