FDA Radiology AI Devices

Methinks NCCT Stroke is an AI-based software designed to assist clinicians by automatically analyzing non-contrast head CT scans to detect signs of intracranial hemorrhage and large vessel occlusion. It prioritizes and notifies suspected positive cases to improve workflow efficiency and triage in stroke care, offering rapid alerts that support clinical decision-making without replacing standard diagnostic procedures.

JLK-SDH is an AI-powered software that analyzes non-contrast CT head images to detect suspected subdural hemorrhage (SDH). It assists radiologists by notifying them of potential cases in a parallel workflow to standard care, enabling quicker communication and prioritization for specialist review. This helps clinicians promptly identify and manage patients with SDH, improving workflow efficiency and potentially patient outcomes. The device is intended for notification purposes only and does not replace diagnostic evaluation.

JLK-ICH is an AI-powered software that analyzes non-contrast CT scans of the head to detect suspected intracranial hemorrhage. It provides automated notifications to clinicians to prioritize review, allowing faster communication and potentially improving patient outcomes. The software works alongside standard care without replacing diagnostic evaluations.

NeuroICH is a software tool designed to analyze non-contrast CT scans of the head using artificial intelligence to detect signs of intracranial hemorrhage. It provides notifications to specialist clinicians via a mobile app, helping to prioritize patient care without replacing standard diagnostic procedures.

uAI Easy Triage ICH is an AI-powered software designed to assist radiologists by analyzing non-contrast head CT images to detect suspected intracranial hemorrhage (ICH). It helps prioritize and triage cases by flagging images that show possible bleeding in the brain, ensuring faster notification and workflow efficiency in hospital settings.

Hyper Insight - ICH is an AI-powered clinical software tool that analyzes brain CT scans to detect suspected intracranial hemorrhage. It provides timely notifications to medical specialists to prioritize patient care, helping clinicians triage potential emergencies more efficiently. The software serves as a supplementary notification aid rather than a definitive diagnostic tool, enhancing workflow efficiency and supporting faster treatment decisions.

Heuron ICH is an artificial intelligence software that assists medical specialists by analyzing non-contrast head CT images to identify suspected cases of intracranial hemorrhage. It provides notifications and compressed preview images to help prioritize patient care and streamline workflow, without modifying the original images or serving as a diagnostic device.

syngo.CT Brain Hemorrhage by Siemens Medical Solutions is an AI-powered software that helps radiologists prioritize CT scans suspected of having intracranial or subarachnoid hemorrhages. It analyzes head CT images to flag cases for earlier review, improving workflow efficiency. This software is not for diagnosis but supports clinicians by highlighting urgent cases based on AI detection of hemorrhages.

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.