FDA Radiology AI Devices

Annalise Enterprise is an artificial intelligence software designed to analyze chest X-ray images to detect several critical findings such as pneumothorax, tension pneumothorax, pleural effusion, pneumoperitoneum, and vertebral compression fractures. It supports clinicians by prioritizing studies containing these suspected findings to streamline and accelerate patient care workflow, aiding in triage and worklist management.

The ULTRA 1040 is a portable X-ray device designed for use by trained physicians or technicians to capture X-ray images of patients' extremities. It allows for flexible diagnostic imaging outside traditional settings, helping clinicians assess bone and joint conditions conveniently. It supports use with an X-ray detector and image processing software for image acquisition and processing.

The Wireless/Wired X-Ray Flat Panel Detectors by Allengers Medical Systems Limited are digital imaging devices used with specialized software to capture and process X-ray images of all body parts for general radiographic applications. They convert X-rays into high-quality digital images, aiding radiologists in diagnosis by replacing traditional film-based systems.

The Nanox.ARC X is a stationary digital tomosynthesis X-ray system designed to create detailed tomographic images of various body parts, including musculoskeletal, pulmonary, abdominal, and sinus regions. It complements traditional X-ray imaging by producing slice images that reduce the overlap of structures, enhancing diagnostic clarity. The system operates multiple low-dose X-ray sources sequentially and reconstructs images either locally or via a secure cloud, aiding clinicians in more precise diagnosis and patient care in adult patients under professional healthcare settings.

Second Opinion Periapical Radiolucency Contours is an AI-based computer-aided detection software that helps dentists identify areas of periapical radiolucency in dental X-rays by outlining suspected regions with polygonal contours. It supports dental professionals by providing a second opinion when reviewing periapical radiographs, potentially improving detection accuracy and aiding clinical decisions.

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.

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.

The EXPD-N series by DRTECH Corporation is a digital flat panel X-ray detector designed for use in digital radiography. It replaces traditional film or screen-based X-ray systems and aids clinicians by providing high-quality digital images for general diagnostic imaging of human anatomy in both adults and children. It supports improved imaging performance and faster image acquisition for better diagnosis.