FDA Radiology AI Devices

DrAid for Radiology v1 is an AI-based software tool that analyzes adult chest X-rays to identify features indicative of pneumothorax. It helps prioritize cases in the radiology workflow by notifying the system of potentially critical images, assisting clinicians in timely review without providing direct diagnoses or replacing clinical judgment.

BriefCase is a software device that uses artificial intelligence to analyze chest X-ray images for signs of pneumothorax. It notifies trained medical specialists of suspected positive cases via a desktop app to help prioritize patient care. The software works alongside standard clinical workflows without altering the original images or diagnostic process.

ClearRead Xray Pneumothorax is an AI-powered software tool designed to analyze adult chest X-rays and identify signs of pneumothorax larger than 5 mm. It functions as a triage system that notifies radiologists about suspected urgent cases, helping prioritize the review workflow but not replacing diagnostic interpretation.

Annalise Enterprise CXR Triage Pneumothorax is a software tool that uses artificial intelligence to analyze adult chest x-rays for signs of pneumothorax and tension pneumothorax. It assists trained clinicians by automatically prioritizing and triaging cases in their worklist, enabling faster attention to urgent findings. The device integrates with hospital imaging systems and helps optimize workflow without replacing clinical judgment.

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.

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.

BriefCase for RibFx is an AI-powered software that assists medical specialists by analyzing chest CT scans to identify and flag cases with three or more acute rib fractures. It provides notifications and low-quality preview images on a desktop application, helping radiologists prioritize and review urgent cases sooner, thereby improving workflow efficiency and patient care.

The uAI EasyTriage-Rib is a software tool that uses artificial intelligence to analyze CT chest images and help radiologists prioritize trauma cases with suspected multiple acute rib fractures. It assists in workflow triage by flagging cases with suspected findings, allowing faster and more efficient patient management without altering the original medical images or making diagnoses itself.

AIMI-Triage CXR PTX by RADLogics is an FDA-cleared AI software that helps hospital radiologists prioritize adult chest X-rays that might show moderate to large pneumothorax. It analyzes chest X-rays and flags urgent cases for quicker review, improving workflow and patient care by notifying radiologists of possible urgent findings without replacing full diagnosis.

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.