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 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

Viz ICH is an AI-based software tool designed to analyze non-contrast CT scans of the brain for signs of intracranial hemorrhage (ICH). When the software detects suspected ICH, it sends notifications to neurovascular or neurosurgical specialists, helping speed up patient care by alerting clinicians early. The system includes a backend server for image processing and a mobile app for reviewing images in a non-diagnostic way for quick assessment and communication.

FDA #
K193658
Product Code
QAS

BriefCase by Aidoc Medical, Ltd. is an AI-powered radiological software that helps radiologists quickly identify head CTA images with suspected Large Vessel Occlusion. It provides notifications and compressed preview images in parallel to standard image interpretation to speed triage and prioritization, enhancing clinical workflow without replacing full diagnostic review.

FDA #
K192383
Product Code
QAS

DeepCT is an AI software tool that analyzes non-contrast CT brain images in acute settings to detect signs of intracranial hemorrhage. It sends notifications to specialists to prioritize and review cases quickly, improving workflow and potentially speeding patient care. It supports, but does not replace, radiologists' diagnostic process.

FDA #
K182875
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

ContaCT is an AI-powered software developed by Viz.AI that analyzes brain CT angiogram images to detect suspected large vessel occlusions, a critical cause of stroke. The software notifies specialists quickly, allowing for faster clinical review and potentially earlier treatment, which can reduce disability from stroke. It integrates into hospital workflows, sending alerts in parallel to standard care without replacing diagnostic decisions.

Product Code
QAS
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