FDA Radiology AI Devices

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 AI-based software tool designed to assist clinicians by analyzing adult chest X-ray images to detect features suggestive of vertebral compression fractures. It integrates with hospital image and order management systems to prioritize cases with potential fractures, facilitating timely review in clinical workflows such as Bone Health and Fracture Liaison Service programs. The device supports clinicians in identifying urgent cases but does not replace clinical decision-making.

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.

BriefCase is an AI-powered software by Aidoc Medical that automatically analyzes chest CT scans to identify cases with three or more acute rib fractures. It sends notifications with preview images to help radiologists prioritize these critical cases for faster review, enhancing clinical workflow and patient care without altering original images or providing primary diagnoses.

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.

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.