FDA Radiology AI Devices

ADAS 3D is an AI-powered software tool that processes cardiac MRI and CT images to support visualization, quantification, and analysis of heart structures and myocardial fibrosis in patients with cardiovascular disease. It aids medical professionals in making informed decisions for cardiac care by providing detailed 3D imaging data, especially for pre-planning and during electrophysiology procedures.

Overjet Image Enhancement Assist is a software tool that improves the quality of dental x-ray images such as bitewing, periapical, and panoramic images. It uses AI algorithms to reduce noise and enhance contrast and sharpness, helping dental professionals see clearer images for better diagnosis. The software operates within the Overjet device platform and is intended to be an optional enhancement tool, not a replacement for existing imaging systems.

uAI Portal is a medical imaging software system developed by Shanghai United Imaging Intelligence Co., Ltd. It provides tools to view, manipulate, and evaluate CT angiography studies focused on vascular structures within various anatomical regions including lower extremities, head and neck, coronary arteries, pulmonary arteries, and aorta. The software uses AI-based segmentation algorithms to help clinicians analyze vessel structures accurately and efficiently, making it easier to interpret complex vascular imaging data and facilitating clinical decision-making.

Imbio PHA (4.0.0) is a medical image processing software designed to measure the maximal diameters of the heart's right and left ventricles, the main pulmonary artery, and the ascending aorta from CT pulmonary angiography scans. It uses artificial intelligence to identify and measure these structures, providing annotated images and summary reports to assist clinicians in evaluating cardiovascular health.

MI View&GO by Siemens Medical Solutions USA, Inc. is medical diagnostic software designed to assist healthcare professionals in viewing and analyzing medical images from multiple modalities including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids in radiotherapy treatment planning by providing users with tools for image manipulation, quantification, and comparison at or near the scanner console, enhancing workflow efficiency and diagnostic accuracy.

The syngo.via MI Workflows, including Scenium and syngo MBF, is a multi-modality software platform developed to assist healthcare professionals in viewing, manipulating, quantifying, and analyzing medical images from various imaging modalities, including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids physicians in radiotherapy treatment planning by harmonizing PET data and providing standardized analysis tools such as brain amyloid quantification.

The Overjet Charting Assist is a software system that helps dental professionals analyze 2D dental X-rays by detecting natural dental structures like tooth anatomy and numbering, as well as restorative dental work such as crowns and implants. It supports clinicians by automating dental chart creation from images, aiding in more precise and efficient dental assessments.

NeuroQuant is an automated software device designed to help clinicians by providing automatic labeling, visualization, and volumetric measurement of brain structures and lesions from MRI scans. It enhances clinical workflow by delivering segmented images and morphometric reports that can be reviewed and compared to normative data, aiding in diagnosis and monitoring of neurological conditions.

qCT LN Quant is a software tool that helps radiologists track, assess, and quantify lung nodules seen in CT scans. It provides volumetric and diameter measurements of user-selected nodules, with 2D and 3D visualizations, and uses AI algorithms to assist in characterizing nodules including measurements like volume doubling time and density. It supports clinical decision-making with integrated risk calculators based on established lung nodule malignancy and management guidelines.

CoLumbo is a software tool that helps radiologists and spine surgeons analyze MRI images of the lumbar spine by automatically segmenting anatomical features and measuring spine structures. It identifies out-of-range measurements and assists users in documenting findings, streamlining the review and reporting process without making any medical diagnosis.