FDA Radiology AI Devices

syngo.CT Lung CAD is an AI-powered software tool that helps radiologists detect solid pulmonary nodules in chest CT scans. Acting as a second reader, it alerts clinicians to potential nodules that might have been overlooked during their initial review, thereby improving diagnostic accuracy and patient care.

Broncholab is a software tool that helps doctors analyze CT scans of the lungs by providing detailed quantitative information about lung volume, airway volume, lung density, and other pulmonary tissue characteristics. It assists in the diagnosis and follow-up of lung abnormalities by creating 3D models and measurements from CT images, supporting clinical decision-making.

The Behold.ai Red Dot device is an AI-powered software platform that assists radiologists by automatically analyzing adult chest X-ray images to identify suspected pneumothorax cases. It integrates into clinical workflows by notifying radiologists through PACS or workstation systems to prioritize these cases for faster review. It is intended to support, but not replace, clinical decision-making.

HealthCXR is a software tool that uses artificial intelligence to analyze adult chest X-ray images for signs of pleural effusion, a condition where fluid accumulates around the lungs. It automatically alerts radiologists by prioritizing critical cases in their worklists, helping them to review urgent scans faster. The software operates alongside the standard care workflow and does not provide a diagnosis on its own, but assists clinicians in managing their caseload more efficiently.

AI-Rad Companion (Cardiovascular) is an AI-powered software that analyzes previously acquired CT chest images to segment the heart and aorta, quantify coronary calcium, and measure aortic diameters. It assists clinicians by providing quantitative and qualitative cardiovascular assessments to support diagnosis and evaluation in emergency, specialty, and general practice care.

Critical Care Suite is an AI-powered software by GE Medical Systems designed to analyze frontal chest X-ray images and detect pneumothorax, a potentially life-threatening condition. It flags suspicious images in the image management system to help radiologists prioritize urgent cases, improving workflow efficiency and patient care. The software runs seamlessly without delaying image processing and helps reduce the report turnaround time for critical chest X-rays.

AI-Rad Companion (Pulmonary) is advanced software designed to analyze CT images of the lungs. It helps clinicians by segmenting lung regions, measuring lung volumes, identifying areas with abnormal tissue density, and detecting lung lesions including solid pulmonary nodules. This enables efficient and precise assessment of lung disease from existing CT scans, supporting better diagnosis and treatment decisions in emergency and specialty care.

HealthPNX by Zebra Medical Vision Ltd. is an AI-powered software that analyzes chest X-rays to identify suspected pneumothorax cases. It helps radiologists prioritize urgent cases by providing passive notifications on their PACS worklist, reducing triage time and potentially improving patient care efficiency. It does not modify images or provide diagnostic decisions independently but supports clinical assessment workflows.

The Lung Vision System is a medical imaging tool designed to assist clinicians by processing radiological images of the lungs. It helps improve visualization and analysis, aiding in the detection and diagnosis of lung-related conditions.

LungQ by Thirona Corporation is a software tool that processes CT chest scans to help physicians quantitatively analyze pulmonary tissues. It performs 3D segmentation of lung regions, volumetric and density evaluations, fissure analysis, and generates reports to support diagnosis and monitoring of lung conditions.