FDA Radiology AI Devices

The SIGNA Victor is a 1.5 Tesla whole body MRI scanner designed to provide high-resolution diagnostic images quickly and with a high signal-to-noise ratio. It produces images in multiple planes and supports imaging of the entire body, including brain, spine, joints, heart, abdomen, and more, aiding clinicians in diagnosing a variety of conditions.

The MR 5300 and MR 7700 R11 MR Systems by Philips are advanced magnetic resonance imaging (MRI) devices that provide high-quality images of the internal structures of the head, body, or extremities. These systems help clinicians by enabling detailed visualization, which supports diagnosis, therapy planning, and interventional procedures. The devices incorporate updated software (R11) and minor hardware enhancements, including AI-powered SmartSpeed features that improve image acquisition and reconstruction, facilitating faster and more accurate MRI scans.

The Swoop Portable MR Imaging System by Hyperfine is a bedside MRI device that allows clinicians to capture magnetic resonance images of the head without moving the patient. It utilizes advanced deep learning-based image reconstruction to improve image quality, reducing noise and blurring. This portable device helps provide timely diagnostic information in critical care settings where traditional MRI is difficult.

The uMR Omega with uWS-MR-MRS is a magnetic resonance imaging (MRI) system combined with advanced software solutions designed for viewing, manipulating, and analyzing MR images. It includes features such as AI-assisted image reconstruction and multiple post-processing tools that aid clinicians in evaluating anatomical and functional information. This helps radiologists and physicians diagnose more effectively by providing enhanced image quality and quantitative assessment capabilities.

The MAGNETOM Sola, MAGNETOM Altea, and MAGNETOM Sola Fit are MRI systems designed to produce detailed cross-sectional images and spectroscopic data of the head, body, and extremities. They support advanced imaging workflows and reconstruction frameworks, helping clinicians diagnose medical conditions by providing clear internal images and physical parameters. The system can also assist in interventional procedures with MR-compatible devices.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a bedside portable MRI device designed to produce internal head images using magnetic resonance imaging. It allows clinicians to perform imaging at the point of care when full diagnostic exams are not practical. Its AI-enabled reconstruction algorithm enhances image quality by reducing noise and blurring for multiple MRI sequences, helping physicians with diagnosis.

The MAGNETOM Free.Max and MAGNETOM Free.Star are advanced magnetic resonance imaging (MRI) systems designed by Siemens. These devices produce detailed cross-sectional images of the body to help clinicians visualize internal structures and diagnose various conditions. Featuring new software and hardware enhancements, they provide improved imaging workflows, patient comfort with different bore sizes, and automated shoulder examination support, aiding physicians in accurate diagnosis and patient management.

The Swoop Portable MR Imaging System is a bedside portable MRI device designed for producing images of the internal structure of the head when full diagnostic exams are not feasible. It uses advanced AI-based image reconstruction algorithms to enhance image quality with reduced noise and blurring, aiding clinicians in diagnosis at the point of care, such as emergency rooms or critical care units.

AIR Recon DL is a deep learning-based software feature for GE Healthcare MRI systems that improves image quality by reducing noise and ringing artifacts in MRI images. It helps clinicians by enabling shorter scan times without losing image clarity, thus improving patient comfort and diagnostic accuracy across multiple anatomies and MR field strengths.

The Achieva, Ingenia, Ingenia CX, Ingenia Elition and Ingenia Ambition MR Systems by Philips are advanced 1.5 and 3.0 Tesla MRI machines that produce high-quality cross-sectional images to help physicians diagnose various conditions. They include AI-enhanced features like SmartSpeed AI for faster image acquisition without loss of quality, aiding clinicians with quicker and improved diagnostic imaging.