FDA Radiology AI Devices

The Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR is an advanced 3 Tesla MRI system by Canon Medical Systems. It utilizes AI-based deep learning reconstruction to improve image quality across various anatomical regions. This helps clinicians by providing clearer, high-quality diagnostic images of the head, body, and multiple specific anatomical areas, improving diagnostic confidence without changing the existing hardware or basic MRI functions.

MaxFOV 2 is a software option for GE CT scanners that uses deep learning to extend the display field of view in CT images beyond the scanner's nominal field, providing improved visualization of patient anatomy, especially useful in radiation therapy planning and for large patients. This helps clinicians obtain more complete images for diagnosis and treatment planning when parts of the body are outside standard scan coverage.

SubtleMR is a software tool that enhances MRI images by reducing noise or increasing sharpness using a convolutional neural network algorithm. It works with various MRI scans of the head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal areas to help radiologists obtain clearer images for better interpretation and diagnosis.

NinesMeasure is a software tool designed to help trained radiologists measure the size of pulmonary nodules on adult thoracic CT scans. It uses artificial intelligence to automatically calculate long and short axis diameters of nodules, providing quantitative information for better assessment and tracking over time. This tool assists clinicians by streamlining nodule measurement, though it is not intended to replace full patient evaluation or diagnosis.

TruPlan is a medical software that helps doctors visualize and measure heart and vessel structures from CT scans to assist in planning the left atrial appendage closure procedure. It provides tools such as segmentation, 3D rendering, and simulated imaging views to support detailed anatomical assessment and device sizing for safe and effective treatment.

Synapse 3D Base Tools v6.1 by Fujifilm is an advanced medical imaging software designed to assist trained medical professionals in viewing, analyzing, and interpreting medical images from a variety of modalities such as CT, MRI, PET, and ultrasound. It provides multi-planar reconstructions, 3D volume rendering, image fusion, segmentation using deep learning algorithms, and other sophisticated tools to support diagnosis and treatment planning, enhancing the workflow and accuracy for radiologists and clinicians.

The LVivo Software Application is an AI-powered tool that automates the analysis of ultrasound images, specifically echocardiograms, to measure cardiac functions such as left and right ventricular function and bladder volume. It helps clinicians accurately and efficiently assess heart structure and function in patients, supporting better diagnosis and management of heart conditions.

QUIBIM Precision Prostate (qp-Prostate) is software designed to assist trained professionals such as radiologists in viewing and analyzing prostate MRI scans. It offers advanced post-processing features to quantify diffusion and perfusion characteristics, helping clinicians better visualize prostate tissue and complete structured reports. This software enables improved image analysis and decision support without performing a direct diagnostic function.

Visage Breast Density is a software application designed to analyze mammography images and classify breast density into categories according to the ACR BI-RADS Atlas 5th Edition. It uses a convolutional neural network to assist radiologists by providing adjunctive information about breast tissue composition, making breast density assessment more efficient.

The Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit is a 1.5 Tesla MRI system from Canon Medical Systems designed to produce detailed cross-sectional images of the head or body for diagnostic use. It includes AI-based image reconstruction technology (AiCE) that enhances image quality and processing for a variety of anatomical regions, helping clinicians make more accurate diagnoses.