FDA Radiology AI Devices

The NIDO Baby Magnetic Resonance Imaging System is a specialized MRI device designed for imaging the brains of newborns and infants. It provides high-quality axial, sagittal, coronal, and oblique images of the internal structure of neonatal or infant heads, aiding doctors in diagnosis without using ionizing radiation. This system features a 0.35 Tesla permanent magnet with an open design optimized for safe and comfortable neonatal imaging.

MROpen Evo is a whole body MRI diagnostic device designed to produce high-resolution images of various body structures in multiple orientations, including brain examination with DWI sequence. It facilitates imaging for patients who might benefit from standing scans or have movement disorders, and incorporates advanced software features like Compressed Sensing for faster image acquisition. The device uses superconducting magnets cooled by a cryocooler and is intended for diagnostic imaging with certain limitations in cardiac, breast, lung, and upper abdominal imaging.

SIGNA MAGNUS is a high-performance, head-only 3.0T magnetic resonance imaging (MRI) system designed to capture detailed images of the head, neck, TMJ, and limited cervical spine. It supports various imaging planes and advanced diffusion techniques to produce high-resolution images that assist physicians in diagnosis, helping improve patient care through better imaging quality and shorter scan times.

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.