FDA Radiology AI Devices

Opulus™ Lymphoma Precision is an AI-powered software tool designed to help physicians analyze whole-body FDG-PET/CT scans of patients with FDG-avid lymphomas. It automatically segments and visualizes lymphoma lesions and calculates the total metabolic tumor volume. This supports physicians by reducing the manual workload and assisting in more efficient interpretation of PET/CT images, although final decisions remain with the radiologist.

The uMR Omega is a 3.0 Tesla superconducting MRI system designed to capture detailed anatomical and functional images of the head, body, and extremities. It supports various advanced imaging sequences and features, including new RF coils and enhanced image processing algorithms like SparkCo for artifact correction and Inline ECV for quantitative mapping. This device helps clinicians diagnose by providing high-quality images and assisting workflows such as breast biopsy and cardiac function analysis.

SCENARIA View Phase 5.0 is a multi-slice CT system that acquires axial volumes of the whole body in various scan modes. It includes AI-based features such as AutoPose that automatically recognizes and sets scan ranges for body parts, improving workflow and scan accuracy. The system supports high-quality imaging with motion correction and provides enhanced post-processing capabilities to assist clinicians in diagnosis and interventional guidance.

The uCT ATLAS Astound with uWS-CT-Dual Energy Analysis and uCT ATLAS with uWS-CT-Dual Energy Analysis are advanced CT imaging systems that produce cross-sectional whole-body images using X-rays. They incorporate AI-based technologies to enhance image reconstruction, reduce artifacts, and improve diagnostic quality, particularly for cardiac imaging and lung cancer screening. The systems support low dose CT for early lung nodule detection and use dual energy imaging for detailed tissue characterization.

The Spectral CT system by Philips is an advanced CT scanner that acquires dual-energy X-ray data to provide detailed cross-sectional images of the body. This technology enables the analysis of different materials' chemical composition and improves visualization of anatomical and pathological structures, aiding clinicians in diagnostic imaging and treatment planning across multiple clinical areas including radiology, cardiology, and oncology.

VersaViewer is a medical image management and processing system software developed by GE Medical Systems SCS. It supports 2D, 3D, and 4D medical images from multiple modalities and provides customizable layouts for multimodality review. It offers measurement, annotation, segmentation tools, and advanced visualization options to assist trained healthcare professionals in diagnostic workflows. The software includes an optional One View feature for automated multi-organ segmentation using deep learning, enhancing radiologists' efficiency in interpreting spectral CT exams. It is intended to assist physicians in diagnosis, though physicians retain final decision-making responsibility.

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 SIGNA Prime Elite is a whole body magnetic resonance imaging (MRI) scanner that offers high resolution and short scan times. It produces detailed images across multiple planes of the entire body, including the head, spine, heart, and musculoskeletal regions, assisting physicians in diagnostic interpretation to support detection and evaluation of various medical conditions.

The BodyTom 64 is a computed tomography (CT) system designed for pediatric and adult imaging within an 85 cm aperture. It offers high-resolution CT scans with preset dose settings based on patient age and weight and can be used with or without contrast. The system is specifically intended for various diagnostic uses, including low dose lung cancer screening when used with established protocols. Its design includes a mobile gantry with a rotating disk x-ray generator and detector array, facilitating imaging at different clinical locations. The system includes an interventional radiology package that enhances clinical workflow and user experience.

The NAEOTOM Alpha series by Siemens is a computed tomography (CT) scanner system that produces detailed cross-sectional images using X-rays. These images aid clinicians in diagnosis, treatment, radiation therapy planning, and interventions, including low-dose lung cancer screening for high-risk populations. The system uses advanced software for image reconstruction and supports various post-processing applications to deliver clear and precise imaging for multiple clinical uses.