FDA Radiology AI Devices

VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage is an AI-based software tool that analyzes adult chest X-rays to detect critical conditions such as pleural effusion and pneumothorax. It prioritizes cases in the clinical workflow by providing passive notifications in the radiologist's PACS or workstation, helping healthcare professionals manage urgent cases efficiently. The software supports DICOM and common image formats and is intended to assist rather than replace clinical decision-making.

SmartChest is an AI software that analyzes frontal chest X-rays to detect suspected pleural effusion and pneumothorax. It helps radiologists by prioritizing cases with critical findings in their worklists, improving workflow efficiency. The software passively notifies the radiologist without replacing clinical decision-making.

Radify Triage is an AI-powered software that analyzes adult chest X-ray images to detect critical findings like pleural effusion and pneumothorax. It provides a notification within the PACS system to help radiologists prioritize urgent cases, improving workflow efficiency and patient care. It acts as a triage tool to flag suspicious cases but does not replace clinical decision-making.

BraveCX is an AI-based software that analyzes adult chest X-ray images to detect pleural effusion and pneumothorax. It helps radiologists prioritize cases with suspected critical findings by flagging suspicious images in the PACS worklist, enhancing workflow efficiency without providing direct diagnostic decisions.

qXR-PTX-PE is an AI-powered software that assists radiologists by automatically analyzing adult chest X-rays to detect signs of pleural effusion and pneumothorax. It helps prioritize cases by providing case-level outputs within the existing PACS/workstation without altering images or providing direct clinical diagnosis, thereby improving workflow efficiency.

Annalise Enterprise CXR Triage Trauma is an artificial intelligence-based software that assists clinicians by automatically analyzing adult chest X-rays to identify signs of pleural effusion and pneumoperitoneum. It integrates with hospital imaging systems to prioritize urgent cases in the clinical workflow, helping healthcare providers quickly identify critical findings and streamline patient care.

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.

Lunit INSIGHT CXR Triage is an AI-based software tool designed to analyze adult chest X-ray images and identify potentially critical lung conditions such as pleural effusion and pneumothorax. It flags suspicious cases in the radiology workflow, enabling radiologists to prioritize urgent cases more efficiently without altering the standard reading queue. It operates as a supportive notification system and is not intended for standalone 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.