FDA Radiology AI Devices

Rapid CTA 360 by iSchemaView is an AI software designed to assist radiologists by automatically triaging and notifying critical findings on CT angiography scans. This helps clinicians quickly identify urgent conditions and prioritize patient care effectively.

Mosaic V1.0.1 is a medical image analysis software that processes CT angiography images to help trained clinicians analyze arterial diseases such as atherosclerosis and aneurysmal disease. It offers 3D vessel visualization, measurements of vessel diameter, stenosis, and tissue volumes, supporting clinical decision-making though it does not provide direct diagnoses.

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.

uWS-Angio Basic is medical image management and processing software designed to handle X-ray angiographic, CT, and MRI images. It provides clinicians with tools for viewing, processing, calibration, and measurement of 2D and 3D vascular images, supporting improved diagnosis and treatment planning in angiography and related procedures.

The uAngio AVIVA CX is an advanced angiographic X-ray system designed to assist clinicians during diagnostic, interventional, and surgical procedures such as cardiac and neuro-angiography. It provides precise, intelligent image guidance with 2D and 3D imaging capabilities and software features such as camera-assisted recognition and voice control, helping to improve procedural accuracy and patient safety.

cmAngio® (V1.6) is an AI-based software product designed to assist radiologists by automatically processing radiological images, potentially helping to detect or analyze vascular conditions.

SERV MEDICAL CDSS is a medical image processing software designed for trained professionals, enabling viewing, processing, and analysis of imaging data acquired with Digital Subtraction Angiography (DSA). It helps clinicians visualize large vessels and supports clinical decision making by providing comprehensive image viewing and analysis capabilities on standard hardware.

3DXR is a post-processing software application by GE Healthcare designed to perform three-dimensional reconstruction of images obtained through 3D acquisition modes of X-ray interventional systems. It incorporates a new Deep-Learning option, CleaRecon DL, to reduce streak artifacts in images, enhancing image clarity to assist physicians in diagnosis, surgical planning, interventional procedures, and treatment follow-up.

TeraRecon Aorta.CT is a software that automatically segments and labels key anatomical landmarks of the aorta from contrast CT Angiography scans. It helps trained medical professionals by providing 3D visualizations and measurements to assist in patient management and procedure planning, without altering the original scan data or providing diagnosis.

BriefCase-Quantification is an AI-based software that analyzes contrast-enhanced CT scans to measure aortic diameters at key anatomical landmarks, helping clinicians assess normal and aneurysmal aortas. It processes CT images in a cloud environment, produces measurement results for review, and is intended to assist but not replace radiologist evaluations.