FDA Radiology AI Devices

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.

VUNO Med-DeepBrain is an AI-powered medical software designed to automatically label, quantify, and visualize brain structures and lesions from MR images. It helps clinicians by automating manual brain segmentation processes, providing volumetric data along with visual color maps and reports, facilitating brain diagnosis and tracking over time in a clinical environment.

Jazz is a semi-automatic medical image processing software designed to assist physicians in labeling, visualizing, and measuring volumes of brain structures from MRI scans. It is intended for use with patients diagnosed with multiple sclerosis or brain metastases, enabling physicians to review, correct, and confirm segmentations before generating radiological reports, thereby supporting clinical workflows for brain imaging analysis.

NEUROShield is a software tool that automatically labels, visualizes, and measures the volume of the hippocampus brain structure using 3D MRI images. It uses AI deep learning models to assist neurologists and neuroradiologists by providing fast, accurate volumetric analysis, helping in clinical decision-making and research.

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.

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.

AIRAscore is an AI-powered software that automates the identification, labeling, and volumetric measurement of brain structures from MRI scans. It helps clinicians quickly obtain detailed brain volume information, which can aid in diagnosis and monitoring of neurological conditions by providing consistent and accurate brain segmentation results.

ANDI is a software tool that processes diffusion-weighted MRI brain scans to create 3D maps of white matter tracts. It helps neurologists and radiologists by providing detailed visualization and measurements of brain white matter structures, serving as an adjunct tool for patient assessment without making diagnoses.

OptimMRI is a software tool that helps medical professionals analyze pre-operative brain MRI images by generating 3D annotated models. It supports neurosurgical planning by localizing key brain regions, helping doctors visualize and plan treatments more precisely.

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.