FDA Radiology AI Devices

HealthPPT is an AI-powered software tool that helps radiologists by automatically detecting signs of pneumoperitoneum in adult frontal chest X-rays. It prioritizes urgent cases by notifying the radiology workstation with a low-resolution preview image, enabling faster review of potentially critical findings. The device works alongside standard workflows without altering original images and does not itself diagnose the condition, but aids clinical assessment by highlighting suspicious cases for prompt review.

HealthJOINT is a software product that assists clinicians by using artificial intelligence to create 3D models of knee bones from standard 2D X-ray images. This helps surgeons with preoperative planning for knee surgeries by providing detailed anatomical landmarks and accurate bone reconstructions, improving clinical assessment and surgical preparation.

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.

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.