FDA Radiology AI Devices

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.

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.

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.