FDA Radiology AI Devices

Critical Care Suite with Pneumothorax Detection AI Algorithm by GE Medical Systems is an AI-based software tool that analyzes frontal chest X-rays to detect pneumothorax. It highlights areas of concern and provides a confidence score, helping radiologists and licensed healthcare professionals prioritize cases and accurately diagnose pneumothoraces more efficiently. The software can be integrated with existing PACS and X-ray imaging systems to streamline workflow.

QOCA image Smart CXR Image Processing System is an AI-powered software that analyzes adult chest X-rays automatically to identify suspected pneumothorax cases. It integrates with hospital PACS to notify radiologists so they can prioritize reviewing urgent cases, thus enhancing workflow efficiency. It is not a standalone diagnostic tool, but a triage aid.

The EFAI ChestSuite XR Pneumothorax Assessment System is an AI-powered software tool that helps clinicians prioritize chest X-ray cases suspected of pneumothorax. It uses deep learning to analyze posteroanterior chest X-rays and provides case-level notifications in the existing PACS/workstation workflow, facilitating faster identification and assessment of patients who may have pneumothorax. It supports clinical decision-making by aiding in triage but is not intended for stand-alone diagnosis.

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.

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.

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.