FDA Radiology AI Devices

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.

DeepTek CXR Analyzer v1.0 is a software tool that helps radiologists detect suspicious regions in chest X-rays. Using AI and deep learning, it highlights abnormal areas related to lungs, pleura, heart, and hardware implants to support clinicians in their diagnosis. It doesn't replace radiologists but acts as an aid to improve detection accuracy and efficiency.

Lung-CAD is an AI-based software designed to assist physicians by analyzing chest X-ray images and identifying regions of lung hyperinflation. It highlights these regions with boxes on the X-ray images to support concurrent reading, improving detection accuracy without replacing clinical diagnosis.

Lung-CAD is an AI-powered software that helps physicians by analyzing chest X-rays to identify areas showing interstitial thickening. It highlights these areas with bounding boxes, serving as a concurrent reading aid to improve detection. It does not replace physicians but supports them in interpreting lung images more effectively in adults.

VisiRad XR is an AI-powered software that helps physicians detect suspicious lung nodules and masses on chest X-rays by marking regions of interest. It acts as a second reader to assist radiologists in their interpretations, enhancing diagnostic accuracy for adult patients in outpatient or emergency settings.

Aorta-CAD is an AI-powered software tool designed to assist physicians in analyzing chest X-rays. It detects and highlights areas that may show aortic calcification or dilation, which can indicate chronic aortic conditions. This helps radiologists by drawing attention to suspicious regions, improving diagnostic accuracy without replacing physician judgment.

Auto Lung Nodule Detection is a computer-aided detection software designed by Samsung Electronics to assist physicians in identifying and marking suspected pulmonary nodules between 10 and 30 mm on PA chest X-rays. Integrated into Samsung's digital X-ray systems, it serves as a second reader by highlighting regions of interest on images to support radiologists in their interpretation and improve detection accuracy.

Chest-CAD is a computer-assisted detection software that uses machine learning to analyze adult chest X-rays. It identifies and highlights suspicious regions in various categories like cardiac, lungs, bones, and more, assisting physicians with concurrent reading during diagnosis. This helps improve detection accuracy and clinical workflow efficiency.