FDA Radiology AI Devices

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.

Cina is an AI-powered software designed to assist radiologists by automatically analyzing head CT and CT angiography images to detect intracranial hemorrhage and large vessel occlusion. It provides notifications and preview images to help prioritize and triage cases, enhancing workflow efficiency and potentially enabling faster diagnosis and treatment without replacing standard diagnostic procedures.

Rapid ICH by iSchemaView Inc. is a medical software that uses artificial intelligence to analyze head CT scans for signs of intracranial hemorrhages such as IPH, IVH, SAH, and SDH. It helps hospitals and radiologists prioritize CT images needing urgent attention by providing notifications about suspected hemorrhages, enabling faster diagnosis and treatment without altering the original medical images or replacing diagnostic interpretation.

Viz SDH is an AI-driven software designed to analyze non-contrast CT scans of the head to detect subdural hemorrhages. It provides rapid notifications of suspected cases to neurovascular or neurosurgical specialists through a mobile application, improving workflow efficiency and potentially expediting patient care decisions. The system does not replace diagnostic evaluation but serves as a parallel workflow triage tool to alert specialists early.

BriefCase by Aidoc Medical is an AI-powered software that analyzes non-enhanced head CT images to identify potential intracranial hemorrhage. It assists clinicians by flagging suspect cases and sending notifications with preview images to help prioritize patient care workflow. It operates alongside standard imaging interpretation without altering original medical images.

syngo.CT Brain Hemorrhage is an AI-driven software that assists radiologists by analyzing non-contrast head CT scans to prioritize cases suspicious for acute intracranial hemorrhage. It flags findings to improve workflow efficiency by enabling faster review of urgent cases but is not intended for standalone diagnosis.

InferRead CT Stroke.AI is an AI-powered software that helps hospitals and radiologists prioritize head CT scans by flagging suspected intracranial hemorrhage cases. It analyzes CT images using a deep learning algorithm and highlights potential emergency cases on a worklist, assisting clinicians in faster triage. The software operates alongside standard radiology workflows without altering images or removing cases, improving efficiency in detecting brain hemorrhages.

qER-Quant is an AI-powered software that processes non-contrast head CT scans to automatically identify and quantify key brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift. It helps clinicians by providing volumetric data and visual overlays to aid in diagnosis and monitoring brain conditions over time.

Viz ICH is an AI-powered software tool that analyzes non-contrast CT brain images to detect suspected intracranial hemorrhages. It sends notifications to neurovascular or neurosurgical specialists to facilitate earlier patient review and intervention. The software is integrated with a mobile application for previewing images and managing notifications, though image previewing is non-diagnostic and full diagnosis relies on standard clinical evaluation.