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.

Rapid LVO is a software tool that helps hospitals and radiologists quickly identify and prioritize suspected cases of Large Vessel Occlusion (LVO) in head CT angiography images. It analyzes images using a software algorithm and provides notifications with preview images to assist clinical workflow, without replacing standard diagnostic procedures.

FDA #
K200941
Product Code
QAS

CINA is an AI-based software that assists radiologists by analyzing head CT scans and CT angiographies to flag suspected cases of intracranial hemorrhage and large vessel occlusion. It provides timely notifications with preview images to help prioritize cases for quicker evaluation, improving workflow and patient care without altering original images or making direct diagnoses.

FDA #
K200855
Product Code
QAS

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that assists radiologists by automatically analyzing abdominal CT scans to detect suspected Intra-abdominal Free Gas pathologies. It notifies clinicians of positive findings via a desktop application to help prioritize and triage patient workflow, speeding up clinical decision-making while operating alongside standard care without altering original medical images.

FDA #
K193298
Product Code
QAS

qER is an AI-powered software designed to analyze non-contrast head CT scans to detect critical conditions like intracranial hemorrhage, mass effect, midline shift, and cranial fractures. It assists clinicians by prioritizing urgent scans for review, helping to speed up diagnosis without altering the original image data.

FDA #
K200921
Product Code
QAS

Rapid ICH is an AI-powered clinical software tool designed to help hospital radiology workflows by automatically analyzing non-contrast head CT scans to detect suspected intracranial hemorrhage. It provides alerts and compressed preview images to clinicians through PACS, email, and a mobile app to prioritize urgent cases and aid timely diagnosis and treatment decisions.

FDA #
K193087
Product Code
QAS

HealthICH is an AI software tool designed to analyze non-contrast head CT scans and identify suspected cases of intracranial hemorrhage. It notifies the clinician via the PACS/workstation to prioritize these urgent cases, helping reduce the time to diagnosis and potentially improving patient care. It operates alongside standard workflows and assists clinicians by flagging critical findings for faster review.

FDA #
K190424
Product Code
QAS

BriefCase is an AI-powered software that helps radiologists prioritize cervical spine CT scans by flagging possible fractures. It runs alongside standard image interpretation, notifying clinicians quickly about suspected cases to enable faster patient management, but it is not used for final diagnosis. This helps improve workflow efficiency and timely attention to urgent cases.

FDA #
K190896
Product Code
QAS

BriefCase by Aidoc Medical, Ltd. is an AI-based radiology triage and notification software designed to assist radiologists by automatically analyzing head CT and chest CT pulmonary angiogram (CTPA) images. It detects suspected cases of Intracranial Hemorrhage and Pulmonary Embolism, providing timely notifications and compressed preview images to prioritize urgent cases. This facilitates faster review and potentially improves patient outcomes by allowing earlier intervention, while not replacing standard diagnostic processes.

FDA #
K190072
Product Code
QAS

Accipiolx is an artificial intelligence software tool designed to automatically analyze non-contrast head CT scans to detect signs of acute intracranial hemorrhage. It integrates into hospital radiology networks to prioritize cases suggesting hemorrhage, enabling quicker review by clinicians and faster treatment decisions in acute care settings.

FDA #
K182177
Product Code
QAS

BriefCase is an AI-powered software that assists radiologists by analyzing non-enhanced head CT images to detect suspected intracranial hemorrhages. It provides timely notifications with preview images to prioritize cases for faster review, helping clinicians improve workflow efficiency and patient care without altering original images or making diagnoses.

FDA #
K180647
Product Code
QAS
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