FDA Radiology AI Devices

The ECHELON Synergy V10.0 MRI system by Fujifilm Healthcare Americas Corporation is an advanced magnetic resonance imaging device that produces detailed cross-sectional images of the body using non-ionizing magnetic fields. It helps physicians diagnose various conditions by providing high-quality images reflecting tissue properties such as proton density and relaxation times. This system includes updated software features with AI-powered image processing to improve image quality and workflow efficiency, benefiting both clinicians and patients.

The uMR 680 is a 1.5T superconducting magnetic resonance imaging device that produces detailed anatomical and functional images to assist physicians in diagnosis. It includes components such as magnets, RF coils, and software for imaging the head, body, and extremities, helping clinicians with diagnostic imaging using MRI technology.

The uMR Omega is a 3.0 Tesla superconducting MRI system designed for producing high-quality cross-sectional images and spectroscopic images of the head, body, and extremities. It helps clinicians diagnose by providing detailed anatomical and functional images that can be interpreted by trained physicians. This device is designed to meet industry imaging standards and includes advanced components such as RF coils and gradient amplifiers to ensure high image quality.

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.

The MAGNETOM Viato.Mobile by Siemens is a 1.5 Tesla mobile MRI system designed to be relocated to different locations where imaging services are needed. It produces high-quality MR images of the head, body, and extremities in multiple planes and can also be used during interventional procedures. This helps clinicians diagnose a variety of conditions by providing detailed internal anatomical and functional imaging.

The SIGNA Artist Evo is a whole-body magnetic resonance imaging (MRI) scanner designed to provide high resolution and high signal-to-noise ratio images with short scan times. It supports imaging multiple body regions such as the head, spine, heart, abdomen, pelvis, and musculoskeletal systems. The images produced help clinicians diagnose a wide range of medical conditions based on molecular and anatomical information from MRI signals.

The MAGNETOM Free.Max is a magnetic resonance imaging (MRI) system that creates detailed cross-sectional images of the internal structures and functions of the head, body, and extremities. It includes advanced hardware and software features to enhance image quality and assist clinicians in diagnosing various conditions by providing clear and accurate images.

The SIGNA Premier is a whole body magnetic resonance imaging (MRI) scanner designed to produce high-resolution and high signal-to-noise ratio images in short scan times. It supports imaging of multiple body regions including the head, spine, breast, heart, abdomen, and musculoskeletal system, and uses advanced software featuring deep learning algorithms to automate steps in brain MRI examinations, thereby helping clinicians improve workflow and diagnostic consistency.

IB Neuro v1.0 is software that processes MRI data to create maps showing blood flow and volume in the brain. These maps help doctors evaluate brain perfusion and may assist in clinical decision-making. The software integrates easily with existing MRI systems and PACS to streamline the workflow for clinicians.