FDA Radiology AI Devices

MAGNETOM Terra and MAGNETOM Terra.X are advanced 7 Tesla MRI systems by Siemens designed for capturing high-quality magnetic resonance images primarily of the head and extremities. Equipped with enhanced hardware and AI-based software (Deep Resolve Boost, Sharp, and RxE), these devices improve image quality and reconstruction speed, helping radiologists obtain clearer diagnostic images faster, thus supporting better patient diagnosis and care.

syngo.CT Brain Hemorrhage by Siemens Medical Solutions is an AI-powered software that helps radiologists prioritize CT scans suspected of having intracranial or subarachnoid hemorrhages. It analyzes head CT images to flag cases for earlier review, improving workflow efficiency. This software is not for diagnosis but supports clinicians by highlighting urgent cases based on AI detection of hemorrhages.

syngo.via MI Workflows, including Scenium and syngo MBF, is software that helps healthcare professionals analyze medical images from multiple modalities such as PET, SPECT, CT, and MR. It aids disease management in oncology, cardiology, neurology, and organ function by providing tools for image viewing, quantification, comparison, and radiotherapy planning. The software integrates advanced AI algorithms for automating organ segmentation and supports new workflows such as tau quantification in brain imaging, thus improving diagnostic and treatment planning efficiency.

AI-Rad Companion Brain MR is a software tool that helps clinicians by automatically analyzing MRI brain images. It segments and measures brain structures and white matter hyperintensities, compares these measurements with healthy reference data, and visually presents the results. This assists in evaluating brain changes over time, improving diagnostic workflow and patient monitoring in neurological conditions.

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.

AI-Rad Companion Brain MR is a software tool that helps clinicians analyze and evaluate brain MRI scans. It automatically segments and measures various brain structures, compares them with data from healthy individuals, and presents this information in an easy-to-understand report. This aids in diagnosis and treatment planning for patients with neurological conditions.