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 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 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

BriefCase by Aidoc Medical, Ltd. is an AI-based software that helps hospitals quickly identify and prioritize urgent head CT angiography scans with possible M1 Large Vessel Occlusion. It analyzes images and sends notifications with preview images to clinicians, enabling faster triage without replacing standard image interpretation.

FDA #
K221314
Product Code
QAS

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.

FDA #
K221240
Product Code
QAS

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to help hospital specialists prioritize and triage cases showing possible incidental Pulmonary Embolism. It provides notifications with compressed preview images for early attention but does not replace standard diagnostic review, working alongside existing workflows to speed up urgent case identification.

FDA #
K213886
Product Code
QAS

BriefCase is an AI-powered software that analyzes head CT Angio (CTA) images to assist clinicians by flagging suspected Brain Aneurysm cases above 5 mm, helping prioritize urgent cases and improving workflow efficiency. It provides notifications and preview images but is not intended for primary diagnosis, supporting clinicians to review images faster and potentially reduce time to treatment.

FDA #
K213721
Product Code
QAS

BriefCase is an AI-based software by Aidoc Medical that helps radiologists and trained medical specialists detect and prioritize urgent cases from CT scans of various body regions including head, chest, abdomen, and cervical spine. It flags images with suspected critical findings like fractures, intracranial hemorrhage, pulmonary embolism, intra-abdominal free gas, and large vessel occlusion, presenting low-quality preview images and notifications to accelerate clinical workflow. The software works in parallel with standard of care and does not alter original medical images, serving as a triage and notification aid but not a diagnostic device.

FDA #
K203508
Product Code
QAS
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