FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

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.

FDA #
K231195
Product Code
QAS

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.

FDA #
K223240
Product Code
QAS

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.

FDA #
K222884
Product Code
QAS

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.

FDA #
K221716
Product Code
QAS

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.

FDA #
K221330
Product Code
QAS

Viz LVO is an AI-based software tool designed for hospital networks and clinicians to detect and notify specialists about suspected large vessel occlusions in brain CT angiograms. It facilitates rapid communication and prioritization of cases to improve stroke patient management, providing image previews via a mobile app for informational use to assist timely specialist review.

FDA #
K223042
Product Code
QAS

BriefCase by Aidoc Medical is an AI-powered software that analyzes head CT angiography images to detect suspected large and medium vessel occlusions. It assists trained medical specialists by providing notifications of suspected positive findings to help prioritize and triage cases for faster review. It operates alongside standard workflows without altering original medical images, helping clinicians identify urgent cases more quickly.

FDA #
K220709
Product Code
QAS

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.

FDA #
K222329
Product Code
QAS

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.

FDA #
K221456
Product Code
QAS

BriefCase by Aidoc Medical is an AI-powered software that analyzes CTPA images to detect suspected Pulmonary Embolism cases and notifies clinicians via a desktop application to prioritize these potentially critical cases. It works alongside the standard image interpretation process, helping healthcare professionals triage faster and improve patient care without altering original medical images.

FDA #
K222277
Product Code
QAS
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