FDA Radiology AI Devices

BriefCase-Triage by Aidoc Medical is an AI-powered software that analyzes CT pulmonary angiography images to detect suspected cases of Central Pulmonary Embolism. It provides notifications and low-quality preview images to assist trained clinicians in prioritizing urgent cases, helping speed up patient care without replacing the standard diagnostic process.

Rapid SDH is an AI-based software that helps radiologists prioritize and triage head CT scans by detecting suspected hemispheric subdural hemorrhage (SDH). It analyzes non-contrast head CT images in parallel with standard readings and provides timely notifications with preview images for informational use, assisting clinicians in workflow management to improve patient care.

The EFAI NeuroSuite CT ICH Assessment System by Ever Fortune.AI is AI-based software that analyzes adult non-contrast head CT scans to detect signs of acute intracranial hemorrhage. It helps radiologists prioritize urgent cases by sending triage notifications to their imaging workstations, enabling faster clinical assessment. This tool supports but does not replace clinician review.

Brainomix 360 Triage LVO is an AI-powered software that analyzes CT angiogram images to detect suspected large vessel occlusions in the brain. It assists hospital clinicians by providing priority notifications and compressed image previews via a mobile app or web interface, helping specialists quickly identify and review critical cases in parallel with standard workflows. This tool supports faster triage but is not intended for diagnostic use on its own.

Annalise Enterprise CTB Triage Trauma is an AI software tool designed to analyze non-contrast brain CT scans and assist clinicians by prioritizing cases with features suggestive of mass effect. It integrates with image and order management systems to notify users for earlier review, improving workflow efficiency without replacing clinical decision-making.

Annalise Enterprise CTB Triage Trauma is an AI-based software tool that assists clinicians by analyzing non-contrast brain CT scans to detect signs of vasogenic edema. It helps prioritize cases with suspected findings for earlier review, improving workflow efficiency in medical imaging departments.

Annalise Enterprise CTB Triage-OH is an AI-powered software tool designed to help clinicians prioritize brain CT scans by detecting features suggestive of obstructive hydrocephalus. It integrates with hospital imaging and order management systems to flag and prioritize suspicious cases, enabling faster review and improving clinical workflow without replacing clinical decision-making.

Brainomix 360 Triage ICH is a software tool that uses artificial intelligence to analyze non-contrast brain CT images in acute settings to detect suspected intracranial hemorrhages. It notifies specialists promptly to prioritize patient care and improve workflow efficiency by providing timely alerts via mobile and web applications. It supports clinicians by assisting triage but does not replace diagnostic evaluation.

Annalise Enterprise CTB Triage Trauma is an AI-powered software that assists clinicians by automatically analyzing brain CT scans to identify signs of acute hemorrhages. It helps prioritize studies in the workflow to ensure patients with urgent findings are reviewed faster, improving triage and clinical efficiency. The system integrates with existing imaging management systems and does not provide standalone diagnostic decisions but supports clinicians in managing their workload.

Rapid NCCT Stroke is software that uses artificial intelligence to analyze non-contrast head CT scans and quickly notify clinicians about suspected areas of brain hemorrhage or large vessel blockage. This helps prioritize urgent cases and speeds up patient care, but it is intended to assist—not replace—clinical judgment and diagnosis.