FDA Radiology AI Devices

QFR (3.0) is a software device that processes X-ray angiogram images to provide quantitative analysis of coronary vessels. It uses deep learning and 3D reconstruction from angiographic images to measure vessel dimensions and quantify pressure drops, aiding cardiologists in evaluating coronary artery disease and supporting treatment decisions.

DeepFoqus-Accelerate is an AI-driven software solution designed to improve brain MRI scans by reconstructing accelerated MRI data up to 4 times faster, producing clinical-quality images from undersampled data. It helps radiologists and technologists by enhancing non-contrast brain MRI images from 1.5T or 3T Siemens and GE scanners, making MRI scanning more efficient while maintaining image quality.

HeartFocus (V.1.1.1) is an AI-powered software accessory designed to help healthcare professionals acquire high-quality 2D cardiac ultrasound images. It guides users in real-time to position the ultrasound probe correctly and detects when images meet diagnostic quality. This assists both experienced sonographers and less trained medical professionals in capturing standardized heart views, improving the quality and consistency of cardiac ultrasound exams.

AI-Rad Companion Organs RT is an AI-powered software that automatically segments predefined organs-at-risk from CT and MR images. It helps radiation oncologists by generating contours used in treatment planning, streamlining workflow and improving efficiency. The contours produced are reviewed and edited by trained professionals before use in radiation therapy.

Salix Central is a cloud-based software that helps cardiologists and radiologists analyze cardiac CT scans. It assists in identifying coronary plaques, stenosis, and performing calcium scoring, supporting clinical decision-making in assessing heart disease.

V5med Lung AI is an AI-powered software that helps radiologists detect pulmonary nodules in chest CT images. It automatically analyzes scans and highlights areas with suspected nodules between 4 and 30 mm, acting as a supportive tool to improve accuracy and reduce missed findings. The system integrates easily with clinical imaging workflows and has been clinically validated to improve radiologist performance and reduce reading time.

Rayvolve LN is an AI-powered software that helps radiologists detect and highlight suspected pulmonary nodules on frontal chest X-rays. By serving as a second reader, it aids in reviewing digital radiographs for patients 18 years or older, enhancing diagnostic accuracy without replacing the original chest images.

Rayvolve PTX-PE is an AI-based software tool designed to automatically analyze chest X-ray images for critical findings like pleural effusion and pneumothorax. It helps healthcare professionals prioritize cases by providing study-level notifications for worklist management, thereby improving the efficiency of radiological workflows without replacing clinical decision-making.

The EXPD 114 series are digital flat panel X-ray detectors designed to capture radiographic images electronically instead of traditional film. These devices convert incoming X-rays into visible light and then into digital signals for immediate viewing, storage, and analysis. The detectors are intended for general radiographic diagnosis and can replace traditional film or screen-based systems, assisting clinicians with quick and efficient patient imaging for a wide range of examinations in both adult and pediatric populations.

brAIn™ Shoulder Positioning is a cloud-based software tool that assists shoulder surgeons in planning total shoulder replacement surgeries. It automatically segments CT images of the shoulder using machine learning, allowing clinicians to visualize shoulder anatomy, position implants interactively in 3D, and receive detailed pre- and post-operative measurements and reports, facilitating more accurate and efficient surgical planning.