FDA Radiology AI Devices

The MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A are advanced MRI diagnostic systems that produce detailed cross-sectional images and spectra of the head, body, or extremities. The device uses sophisticated MRI pulse sequences and integrates deep learning-based reconstruction algorithms to produce high-quality images quickly and reliably, aiding physicians in diagnosis and in planning interventional procedures.

AI-Rad Companion Brain MR is software that assists clinicians by automatically analyzing brain MRI scans. It segments various brain structures, quantifies their volumes, and highlights white matter hyperintensities, comparing results to normal data. This helps radiologists make more accurate and efficient evaluations of brain health.

The Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system that produces detailed cross-sectional images of the head and body. It incorporates AI-powered image reconstruction (AiCE) and machine learning technologies to improve image quality, reduce artifacts, and assist in scan planning, helping clinicians obtain clearer and more precise diagnostic images efficiently.

MRCAT Head & Neck is a software tool integrated into Philips MR systems that automatically processes MRI data to create synthetic CT-like images for radiation therapy treatment planning in patients with soft tissue tumors in the head and neck region. It helps clinicians accurately estimate radiation dose distributions without needing a separate CT scan, improving planning precision and patient care.

The MAGNETOM Avanto Fit is a 1.5 Tesla magnetic resonance imaging (MRI) system that produces detailed images of the head, body, and extremities. It helps clinicians visualize internal structures and functions non-invasively, potentially including functional information, and can be used during interventional procedures. The device incorporates advanced hardware and software features to enhance image quality and operational efficiency.

Arterys MICA is a cloud-based medical imaging software that helps healthcare professionals view, process, and analyze medical images from CT and MRI scans. It includes AI modules that assist in cardiac and oncology evaluations by automating image quantification and lesion assessments, supporting clinicians in their diagnostic workflows.

The MAGNETOM Vida with syngo MR XA50A is an MRI system that produces detailed cross-sectional images and spectra of the head, body, or extremities to assist clinicians in diagnosis. It incorporates advanced AI-based image reconstruction algorithms such as Deep Resolve Swift Brain and Deep Resolve Boost to enable faster and higher-quality MRI scans, improving diagnostic workflows and patient outcomes.

The SIGNA Artist Evo is a whole-body magnetic resonance imaging (MRI) scanner designed to provide high resolution and high signal-to-noise ratio images with short scan times. It supports imaging multiple body regions such as the head, spine, heart, abdomen, pelvis, and musculoskeletal systems. The images produced help clinicians diagnose a wide range of medical conditions based on molecular and anatomical information from MRI signals.

SIGNA Hero is a whole body 3.0 Tesla MRI scanner from GE Healthcare that supports high resolution images with a high signal-to-noise ratio and short scan times. It produces detailed images of structures and functions throughout the body to aid physicians in diagnosis by providing axial, sagittal, coronal and oblique images, along with spectroscopic and dynamic imaging capabilities.

SIGNA Prime is a whole body magnetic resonance imaging (MRI) scanner that supports high resolution and fast scan times. It produces detailed images and spectroscopic data of various body regions, helping clinicians diagnose a wide range of conditions by showing the spatial distribution and molecular environment of tissues.