FDA Radiology AI Devices

This product is a family of Philips MRI systems designed to produce detailed images of the body's internal structures. These MRI machines help doctors and clinicians by providing high-quality images that assist in diagnosing a variety of medical conditions across different body regions without using ionizing radiation.

The Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system produced by Canon Medical Systems Corporation. It provides high-quality cross-sectional images of anatomical structures in the head or body, including advanced imaging techniques such as non-contrast enhanced MRA and diffusion imaging. The AiCE Reconstruction Processing Unit uses AI to enhance and speed up the image reconstruction process, helping clinicians obtain clear and detailed MR images for diagnosis.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable ultra-low field MRI device designed to image the internal structure of the head. It provides physicians with useful diagnostic images in environments where full diagnostic examination is not practical. The system uses deep learning reconstruction algorithms to improve image quality and is intended for use at the point of care, such as emergency rooms and intensive care units, enhancing access to MRI imaging in diverse clinical settings.

uMR Jupiter is a 5 Tesla superconducting MRI system developed by Shanghai United Imaging Healthcare Co., Ltd. It generates detailed anatomical and functional images of the head, body, and extremities to assist clinical diagnosis. The device features advanced AI-accelerated image reconstruction technology, enhancing image quality and scan speed, supporting clinicians in making accurate and timely diagnoses.

The Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 is a 1.5 Tesla magnetic resonance imaging (MRI) system developed by Canon Medical Systems. It incorporates AI-based technologies in its reconstruction processing unit (AiCE) to improve image quality, reduce scan time, and assist operators. This system aids clinicians by producing high-resolution images of anatomical structures of the head and body, facilitating accurate diagnosis and efficient workflow.

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.

MAGNETOM Cima.X Fit is a magnetic resonance imaging (MRI) system by Siemens that produces detailed cross-sectional images of the body, head, or extremities. It incorporates AI-driven software features to enhance image quality and accelerate scanning, helping clinicians diagnose by providing clearer and faster MRI scans.

The SIGNA Champion is a 1.5 Tesla whole body magnetic resonance imaging (MRI) scanner designed to produce high-resolution diagnostic images quickly. It can image multiple body regions including the head, neck, spine, chest, abdomen, pelvis, joints, and more, using various scan planes and sequences to help physicians diagnose medical conditions. It supports advanced imaging techniques and uses standard MRI technology enhanced by new software and hardware components to improve image quality and workflow.

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.