FDA Radiology AI Devices

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.

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.

AVIEW Lung Nodule CAD is an AI-powered software designed to help radiologists detect lung nodules on chest CT scans. It automatically identifies nodules between 3 to 20 mm in diameter, providing an additional review layer to ensure suspicious nodules are not overlooked. This tool integrates with medical imaging systems and has been clinically tested to improve detection accuracy and reduce the time radiologists spend reviewing CT scans, ultimately aiding early diagnosis of lung conditions.

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.

AVIEW is a medical imaging software by Coreline Soft that helps clinicians analyze CT scans of the lungs and heart. It automatically segments lung structures, characterizes lung nodules with detailed measurements, and provides calcium scoring of coronary arteries to assess cardiovascular risk. It integrates with AI-based CAD tools and offers cloud and mobile access, making it easier and faster for doctors to diagnose lung and heart conditions.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes frontal chest X-rays to detect and flag cases where an endotracheal tube (ETT) is improperly positioned relative to the carina. It assists hospital networks and trained specialists by prioritizing worklists to enable quicker review of potentially urgent cases. The software operates alongside standard care without altering original images, providing early alerts that help clinicians review and manage patient care more efficiently.

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.

BriefCase is an artificial intelligence software that automatically analyzes CT chest with contrast scans to detect suspected cases of aortic dissection. It helps hospital networks and medical specialists by flagging possible cases to prioritize workflow and speed up patient triage. It provides notifications with preview images for informational use, aiding clinicians in prompt attention to urgent cases without replacing standard diagnostic procedures.

Aorta-CAD is an AI-powered software tool designed to assist physicians in analyzing chest X-rays. It detects and highlights areas that may show aortic calcification or dilation, which can indicate chronic aortic conditions. This helps radiologists by drawing attention to suspicious regions, improving diagnostic accuracy without replacing physician judgment.