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 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

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

Viz SDH is an AI-driven software designed to analyze non-contrast CT scans of the head to detect subdural hemorrhages. It provides rapid notifications of suspected cases to neurovascular or neurosurgical specialists through a mobile application, improving workflow efficiency and potentially expediting patient care decisions. The system does not replace diagnostic evaluation but serves as a parallel workflow triage tool to alert specialists early.

FDA #
K220439
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

Rapid LVO is a software device designed to analyze CT angiography images of the head to help healthcare providers identify suspected large vessel occlusions quickly. By flagging possible cases of ICA or MCA-M1 occlusion and providing notifications with preview images, it supports faster triage and prioritization of medical images, aiding timely clinical decision-making in stroke care.

FDA #
K221248
Product Code
QAS

Rapid PE Triage and Notification (PETN) is an AI-powered software that analyzes CT pulmonary angiography scans to detect and notify clinicians of suspected central pulmonary embolism cases. It assists hospital networks and clinicians by prioritizing patient workflows and flagging positive findings, helping improve timely diagnosis and treatment without altering original medical images.

FDA #
K220499
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
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