FDA Radiology AI Devices

InferRead Lung CT.AI is an AI-powered software tool designed to assist radiologists in detecting and analyzing pulmonary nodules 4mm or larger on chest CT scans of asymptomatic patients aged 55 and older. It provides automatic detection, segmentation, and tracking of nodules over time, helping clinicians identify, measure, and localize lung nodules efficiently. This tool supports early lung nodule detection and monitoring, aiding in lung cancer screening and diagnosis.

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis and uCT ATLAS with uWS-CT-Dual Energy Analysis are advanced CT imaging systems that produce cross-sectional whole-body images using X-rays. They incorporate AI-based technologies to enhance image reconstruction, reduce artifacts, and improve diagnostic quality, particularly for cardiac imaging and lung cancer screening. The systems support low dose CT for early lung nodule detection and use dual energy imaging for detailed tissue characterization.

V5med Lung AI is an AI-powered software that helps radiologists detect pulmonary nodules in chest CT images. It automatically analyzes scans and highlights areas with suspected nodules between 4 and 30 mm, acting as a supportive tool to improve accuracy and reduce missed findings. The system integrates easily with clinical imaging workflows and has been clinically validated to improve radiologist performance and reduce reading time.

Rayvolve LN is an AI-powered software that helps radiologists detect and highlight suspected pulmonary nodules on frontal chest X-rays. By serving as a second reader, it aids in reviewing digital radiographs for patients 18 years or older, enhancing diagnostic accuracy without replacing the original chest images.

AVIEW is a software product that assists physicians by providing quantitative analysis of CT images for lung and cardiac evaluation. It offers segmentation of lung structures, characterization and measurement of lung nodules, calcium scoring of coronary arteries, and integrates computer-aided detection tools. It can be used both on-premises and in cloud environments, supporting remote access via mobile devices or browsers. This software enhances diagnostic accuracy and aids in patient management by automating complex image analysis tasks.

The uCT 780 is a computed tomography (CT) system designed to produce cross-sectional images of the body including head, neck, chest, cardiac and vascular regions. It offers advanced AI-driven image reconstruction to improve image quality and reduce radiation dose, supporting lung cancer screening and various diagnostic tasks. This helps clinicians obtain clearer images for diagnosis while lowering radiation exposure for patients.

The uMI Panorama is a combined PET/CT diagnostic imaging system designed to assist healthcare professionals in detecting and evaluating diseases like cancer, heart, and neurological disorders. It fuses PET metabolic functional imaging and CT anatomical imaging with advanced AI algorithms to improve image quality, reduce artifacts, and enhance diagnostic confidence. It supports PET/CT and single modality CT imaging, including low dose CT lung cancer screening, providing comprehensive information for patient management.

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.

AI-Rad Companion (Pulmonary) by Siemens Healthcare GmbH is software that uses machine learning and deep learning to analyze previously acquired chest CT scans. It helps radiologists and physicians segment lungs and lung lobes, identify and measure solid and sub-solid lung nodules, and track changes over time. This supports clinicians in assessing lung diseases, improving workflow efficiency and diagnostic accuracy.

qXR-LN is an AI-based software device that analyzes frontal chest X-rays to detect and mark suspected lung nodules between 6 and 30 mm. It acts as a second reader to assist physicians like radiologists and pulmonologists, providing adjunctive information to improve detection accuracy without substituting the original image or clinical judgment.