FDA Radiology AI Devices

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.

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.

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.

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.

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.

BriefCase is a software device that uses artificial intelligence to analyze chest X-ray images for signs of pneumothorax. It notifies trained medical specialists of suspected positive cases via a desktop app to help prioritize patient care. The software works alongside standard clinical workflows without altering the original images or diagnostic process.

ClearRead Xray Pneumothorax is an AI-powered software tool designed to analyze adult chest X-rays and identify signs of pneumothorax larger than 5 mm. It functions as a triage system that notifies radiologists about suspected urgent cases, helping prioritize the review workflow but not replacing diagnostic interpretation.

Annalise Enterprise CXR Triage Pneumothorax is a software tool that uses artificial intelligence to analyze adult chest x-rays for signs of pneumothorax and tension pneumothorax. It assists trained clinicians by automatically prioritizing and triaging cases in their worklist, enabling faster attention to urgent findings. The device integrates with hospital imaging systems and helps optimize workflow without replacing clinical judgment.

syngo.CT Brain Hemorrhage is an AI-driven software that assists radiologists by analyzing non-contrast head CT scans to prioritize cases suspicious for acute intracranial hemorrhage. It flags findings to improve workflow efficiency by enabling faster review of urgent cases but is not intended for standalone diagnosis.

The UNiD Spine Analyzer is a web-based software tool that helps surgeons and healthcare providers view and measure spine-related medical images, plan surgical procedures, and simulate surgical strategies. It incorporates machine learning predictive models to assist in preoperative planning and includes a database of implant templates to aid in selecting and placing surgical implants. The software enhances clinical decision-making by providing quantitative radiographic parameters and predictive outputs for spine surgery planning.