FDA Radiology AI Devices

MAGNETOM Free.Max and MAGNETOM Free.Star are magnetic resonance diagnostic devices produced by Siemens that generate high-quality MRI images of the head, body, or extremities in multiple planes. These systems assist clinicians in diagnosis and can be used during interventional procedures with MR-compatible tools. They incorporate advanced AI-powered features to enhance image quality and scanning efficiency.

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.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a portable, ultra-low field MR imaging device designed to produce images of the internal structures of the head. It uses deep learning algorithms to improve image quality by reducing noise and blurring, helping clinicians at the point of care obtain diagnostic information even when full diagnostic exams are impractical.

The Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system developed by Canon Medical Systems Corporation. It produces detailed cross-sectional images of the body and head using advanced AI-powered reconstruction techniques to enhance image quality, reduce artifacts, and improve workflow for clinicians. The device supports various deep learning-based features for motion correction, image resolution enhancement, noise reduction, and automated scan protocols, aiding diagnosis and patient care.

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.

Sonic DL is a software feature by GE Healthcare that uses deep learning to reconstruct cardiac MR images much faster by processing under-sampled data. It allows highly accelerated imaging with preserved image quality, enabling faster and more efficient MRI scans for cardiac assessment in patients of all ages.

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.

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.

The Swoop Portable MR Imaging System by Hyperfine is a bedside portable MRI device designed to produce images of the internal structure of the head. It uses magnetic resonance imaging with advanced image reconstruction algorithms that include deep learning to enhance image quality by reducing noise and blurring. This helps clinicians obtain diagnostic images even when full diagnostic examination is not practical, aiding diagnosis at the point of care in facilities such as emergency and critical care units.

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.