FDA Radiology AI Devices

The MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, and MAGNETOM Altea are magnetic resonance imaging systems designed to produce detailed cross-sectional images and spectra of the head, body, and extremities. These systems aid clinicians in diagnosis by providing high-quality images and offer specialized features such as interventional imaging support and automated workflows, improving reproducibility and efficiency.

The Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR is an advanced 3 Tesla MRI system by Canon Medical Systems. It utilizes AI-based deep learning reconstruction to improve image quality across various anatomical regions. This helps clinicians by providing clearer, high-quality diagnostic images of the head, body, and multiple specific anatomical areas, improving diagnostic confidence without changing the existing hardware or basic MRI functions.

The Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit is a 1.5 Tesla MRI system from Canon Medical Systems designed to produce detailed cross-sectional images of the head or body for diagnostic use. It includes AI-based image reconstruction technology (AiCE) that enhances image quality and processing for a variety of anatomical regions, helping clinicians make more accurate diagnoses.

The SIGNA 7.0T is a high-performance whole-body MRI scanner designed by GE Healthcare to produce high-resolution images of the head and extremities. It supports multiple imaging techniques and pulse sequences to generate detailed anatomical, functional, spectroscopic, and vascular images. The device helps clinicians in diagnosis by delivering high signal-to-noise ratio images with shorter scan times, particularly enabled by its advanced 7.0 Tesla magnetic field strength and optimized hardware.

SIGNA Artist is a magnetic resonance imaging (MRI) scanner designed to produce high-resolution diagnostic images of the whole body. It supports multiple imaging planes and can generate a variety of images including axial, sagittal, coronal, spectroscopic, parametric maps, and dynamic images. The AIR Recon DL software feature enhances image quality by improving signal-to-noise ratio and sharpness, assisting clinicians in diagnosis through clearer MRI images.

The Vantage Orian 1.5T with AiCE Reconstruction Processing Unit for MR is a 1.5 Tesla MRI system from Canon that enhances image quality by using AI-powered noise reduction techniques. This advanced software algorithm uses deep learning to reduce thermal noise and improve signal clarity, especially in brain and knee imaging, helping clinicians obtain clearer and more diagnostically useful MRI images.

The uMR 780 is a 3.0 Tesla MRI system designed to generate high-quality cross-sectional and spectroscopic images of the head, body, and extremities. It assists clinicians in diagnosing various conditions by providing detailed anatomical and functional images, with the option to use contrast agents. The latest version includes software enhancements such as new pulse sequences and AI-assisted image reconstruction methods, improving image quality and analysis.

The SIGNA Premier by GE Healthcare is a whole-body magnetic resonance imaging (MRI) system designed to produce high-resolution diagnostic images of many body parts including the head, spine, joints, and heart. It incorporates a new AI-powered software feature called AIR Recon DL that improves image quality by enhancing signal-to-noise ratio and sharpness, while allowing for shorter scan times. This helps clinicians get clearer images faster, supporting better diagnosis and patient care.

The Vantage Galan 3T with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system from Canon that uses deep convolutional neural networks to reduce thermal noise and improve image quality in MRI scans, particularly for brain and knee regions. This advanced software and hardware combination helps clinicians obtain clearer MRI images, enhancing diagnosis without increasing scan time or contrast use.

The RTHawk HeartVista Cardiac Package is an advanced software system that works with 1.5T and 3.0T MRI scanners to acquire and display real-time and conventional cardiovascular magnetic resonance images. It enables clinicians to obtain detailed heart images quickly and accurately, incorporating automated tools to optimize cardiac scans and improve patient imaging workflows.