FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

The MAGNETOM Vida, Lumina, Aera, Skyra, Prisma, and Prisma fit are advanced magnetic resonance imaging (MRI) systems designed to produce detailed cross-sectional and spectroscopic images of the body, head, and extremities. Equipped with new hardware and software improvements including AI-based image reconstruction techniques, these systems help clinicians obtain high-quality images to assist in diagnosis and interventional procedures.

FDA #
K231560
Product Code
LNH

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.

FDA #
K232482
Product Code
LNH

The ECHELON Synergy MRI system is an advanced 1.5 Tesla MRI scanner that generates high-quality diagnostic images of the head, body, spine, and extremities without ionizing radiation. It incorporates deep learning reconstruction (DLR) and other AI-powered functions like AutoPose and AutoClip to enhance image quality and improve workflow efficiency, helping radiologists diagnose conditions with improved image clarity and reduced scan times.

FDA #
K223426
Product Code
LNH

The Ingenia series MR Systems by Philips Medical Systems Nederland B.V. are advanced MRI devices that produce detailed cross-sectional images and spectra of the head, body, and extremities. Utilizing strong magnetic fields and radio signals, these systems aid physicians in diagnosing diseases, planning treatments, and guiding minimally invasive procedures by providing high-quality images. The new Precise Image software feature enhances image quality by employing deep learning to improve sharpness and reduce noise and artifacts, facilitating better clinical assessment.

FDA #
K223458
Product Code
LNH

MAGNETOM Amira and MAGNETOM Sempra are magnetic resonance imaging (MRI) systems designed to produce detailed images and spectra of the head, body, and extremities. They include advanced AI-powered image reconstruction features such as Deep Resolve Boost and Deep Resolve Sharp, which enhance image quality and sharpness. These systems assist clinicians by providing faster, higher-quality images to improve diagnosis and guide interventions.

FDA #
K223343
Product Code
LNH

The uMR 680 is a 1.5 Tesla superconducting magnetic resonance imaging (MRI) system designed to produce diagnostic-quality images of the head, body, and extremities. It includes a deep-learning based image processing algorithm called DeepRecon for image denoising and super-resolution, enhancing image quality and assisting clinicians in diagnosis.

FDA #
K222755
Product Code
LNH

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.

FDA #
K223439
Product Code
LNH

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.

FDA #
K220332
Product Code
LNH

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.

FDA #
K221733
Product Code
LNH

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.

FDA #
K213583
Product Code
LNH
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