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.

BriefCase-Triage by Aidoc Medical, Ltd. is an AI-powered software designed to assist radiologists by analyzing CT chest and abdomen scans and flagging cases with suspected aortic dissection. It helps medical specialists prioritize urgent cases by sending notifications and preview images, improving workflow efficiency without altering the original medical images or replacing diagnostic interpretation.

FDA #
K251406
Product Code
QAS

BriefCase-Triage is an AI-based radiological software designed to assist clinicians by automatically analyzing contrast-enhanced CT images including the lungs to detect suspected cases of incidental pulmonary embolism. It notifies users with preview images for triage and prioritization, enabling faster attention to critical cases without replacing standard diagnostic workflows.

FDA #
K250248
Product Code
QAS

BriefCase-Triage by Aidoc Medical, Ltd. is an artificial intelligence software that analyzes CT scans including the ribs to identify suspected acute rib fractures. It alerts clinicians with notification and preview images to help prioritize cases for faster review, aiding workflow triage without altering original images or serving as a diagnostic tool. This helps radiologists address urgent findings more efficiently.

FDA #
K243548
Product Code
QFM

BriefCase-Triage is an AI-powered software designed to analyze CT scans of the cervical spine in adults, helping hospital networks and medical specialists by flagging potential fractures. It provides notifications and preview images of suspected cases, enabling faster prioritization of urgent findings to improve clinical workflow and patient care, while not altering original diagnostic images.

FDA #
K242837
Product Code
QAS

BriefCase-Triage is an AI-powered software designed to assist hospital networks and trained radiologists in identifying suspected pulmonary embolism cases from CT pulmonary angiography (CTPA) images. The software analyzes images in parallel with standard interpretation, flags potential positive findings, and notifies clinicians with compressed preview images for triage purposes, helping prioritize urgent cases and reduce turnaround times without replacing standard diagnostic workflows.

FDA #
K241727
Product Code
QAS

BriefCase-Triage by Aidoc Medical is an AI-powered software that analyzes CT pulmonary angiography images to detect suspected cases of Central Pulmonary Embolism. It provides notifications and low-quality preview images to assist trained clinicians in prioritizing urgent cases, helping speed up patient care without replacing the standard diagnostic process.

FDA #
K232751
Product Code
QAS

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that assists radiologists by automatically analyzing chest and abdominal CT scans to detect and flag suspected vertebral compression fractures. It helps prioritize medical images for review, enabling faster triage without altering original images or workflows, thus improving the efficiency of radiological diagnosis and patient care.

FDA #
K222692
Product Code
QFM

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

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
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