FDA Radiology AI Devices

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM is an AI-powered software that automatically analyzes CT angiography scans of the chest region to detect signs of acute aortic syndrome, including aortic dissection and intramural hematoma. It helps radiologists prioritize and triage cases by flagging suspicious studies, enabling faster diagnosis and improved workflow efficiency, although it is not a substitute for clinical decision-making.

The EFAI ChestSuite XR Pleural Effusion Assessment System is an AI-powered software tool designed to assist radiologists by analyzing adult chest X-ray images (taken in the PA view) to identify features suggestive of pleural effusion. It provides notification through PACS/workstations to help prioritize and triage cases for review, improving workflow efficiency. The software does not highlight specific image areas but offers case-level alerts to support clinical assessment.