FDA Radiology AI Devices

MAGNETOM Sola and MAGNETOM Altea are advanced MRI systems designed to produce high-quality transverse, sagittal, coronal, and oblique cross-sectional images. They include AI-powered features such as Deep Resolve Boost and Deep Resolve Sharp for enhanced image reconstruction, improving image quality and diagnostic accuracy. These systems assist clinicians in diagnosis by providing improved visualization of internal structures and functions across the head, body, and extremities, and can also be used during MR-guided interventional procedures.

MAGNETOM Cima.X is an advanced magnetic resonance imaging (MRI) system designed to produce detailed images and spectroscopic data of the head, body, and extremities. It incorporates new and modified hardware and software features including deep learning-based reconstruction methods to enhance image quality and speed, helping clinicians in diagnosis and interventional imaging procedures.

iQ-solutions is a software device designed to automatically identify, annotate, and measure specific brain structures on MRI scans. It helps clinicians by accelerating the quantification process, providing detailed volume analysis reports that support the assessment of brain anatomy and changes over time. The software improves workflow efficiency and consistency in brain MRI analysis.

QP-Brain® is an AI-powered medical imaging software that automatically segments and measures brain structures and white matter hyperintensities from MRI scans. It assists clinicians by providing volumetric data and comparison to normative references, supporting assessment of brain MRIs in adults and adolescents.

The Myocardial Strain Software Application by Circle Cardiovascular Imaging is a software tool that analyzes cardiac MRI images to provide detailed measurements of heart muscle deformation. It helps clinicians assess myocardial function by computing metrics like strain, displacement, velocity, and torsion, supporting diagnostic decisions in patients with suspected heart disease.

MAGNETOM Avanto fit and MAGNETOM Skyra fit are advanced MRI systems designed by Siemens that provide high-quality magnetic resonance imaging. These devices produce detailed cross-sectional images as well as spectroscopic data of the head, body, and extremities, helping physicians diagnose a variety of conditions and support imaging during interventional procedures with MR compatible devices.

MAGNETOM Free.Max and MAGNETOM Free.Star are magnetic resonance diagnostic devices produced by Siemens that generate high-quality MRI images of the head, body, or extremities in multiple planes. These systems assist clinicians in diagnosis and can be used during interventional procedures with MR-compatible tools. They incorporate advanced AI-powered features to enhance image quality and scanning efficiency.

SwiftMR is a software tool that automatically enhances MRI images by reducing noise and increasing sharpness using deep learning techniques. It integrates with medical imaging systems (PACS or MRI machines) to improve image quality, aiding radiologists and clinicians in better interpreting MRI scans.

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.

The MAGNETOM Vida, Lumina, Aera, Skyra, Prisma, and Prisma fit are advanced magnetic resonance imaging (MRI) systems designed to produce detailed cross-sectional and spectroscopic images of the body, head, and extremities. Equipped with new hardware and software improvements including AI-based image reconstruction techniques, these systems help clinicians obtain high-quality images to assist in diagnosis and interventional procedures.