FDA Radiology AI Devices

BriefCase-Quantification is an AI-powered software that automatically measures brain midline shift in non-contrast head CT scans, assisting medical specialists by automating a typically manual measurement process. It provides quantitative analysis and comparative reports over time to help clinicians monitor patients, without altering original images or serving as a standalone diagnostic tool.

BriefCase-Quantification is an AI-powered radiological image management and processing software that analyzes contrast-enhanced CT images to measure the maximum axial diameter of the abdominal aorta. It assists trained medical specialists by providing preliminary measurements to help evaluate normal and aneurysmal abdominal aortas. The tool outputs annotated preview images, which serve as unofficial measurements to aid clinical review, with final decisions left to radiologists.

aprevo® Digital Segmentation is a software tool designed for trained medical personnel to process medical images of the spine, specifically the lumbar area. It uses AI algorithms to automatically segment the spine from DICOM images and generates a 3D model, aiding in clinical planning or design tasks related to spine anatomy.

AI-Rad Companion Brain MR is a software tool that helps clinicians by automatically analyzing MRI brain images. It segments and measures brain structures and white matter hyperintensities, compares these measurements with healthy reference data, and visually presents the results. This assists in evaluating brain changes over time, improving diagnostic workflow and patient monitoring in neurological conditions.

Sonix Health is a software product that assists clinicians in analyzing adult echocardiography ultrasound images. It uses artificial intelligence to automatically classify ultrasound views, segment anatomy, and perform semi-automated measurements, helping physicians quantify cardiac function more efficiently. The software generates reports based on B-mode, M-mode, and Doppler ultrasound images and supports manual verification and adjustment of AI results.

cmAngio V1.0 is an AI-powered software designed to assist radiologists by automatically processing radiological images, helping to improve diagnostic efficiency and accuracy.

VUNO Med-DeepBrain is an AI-powered medical software designed to automatically label, quantify, and visualize brain structures and lesions from MR images. It helps clinicians by automating manual brain segmentation processes, providing volumetric data along with visual color maps and reports, facilitating brain diagnosis and tracking over time in a clinical environment.

HipCheck is a software tool used during hip arthroscopy surgeries that helps surgeons measure the alpha angle related to femoroacetabular impingement (FAI). It processes X-ray images taken during surgery and overlays virtual measurement tools on these images to support clinical decision-making. It also includes a patient-specific report feature for preoperative planning using three-dimensional analyses and visualizations of the hip.

qXR-CTR is an AI-powered software that helps physicians automatically measure the cardiothoracic ratio—the size of the heart relative to the chest—using chest X-ray images. It analyzes images to provide quick, accurate measurements that support clinical decision-making, making the process more efficient for healthcare providers.

DeepXray is an AI-powered software that helps medical professionals analyze knee X-rays by automatically measuring joint space width and assessing signs of osteoarthritis such as sclerosis, joint space narrowing, and osteophytes. It supports clinicians by providing detailed grading based on established radiographic criteria and offers an interactive report for review and editing before finalizing.