FDA Radiology AI Devices

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.

The OTIS 2.1 Optical Coherence Tomography System is a medical imaging device that provides high-resolution, two-dimensional, cross-sectional real-time images of excised human tissue microstructures. It uses non-ionizing optical radiation to create detailed subsurface images, aiding clinicians in evaluating tissue samples. The device automates image acquisition and review, allowing users to identify and annotate regions of interest efficiently, supporting clinical decision-making and improving visualization during tissue evaluation.

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 uAI EasyTriage-Rib is a software tool that uses artificial intelligence to analyze CT chest images and help radiologists prioritize trauma cases with suspected multiple acute rib fractures. It assists in workflow triage by flagging cases with suspected findings, allowing faster and more efficient patient management without altering the original medical images or making diagnoses itself.

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.

ART-Plan is a medical software tool that helps clinicians plan radiation therapy for cancer patients. It supports image registration and fusion of CT, PET, and MRI scans to better visualize tumor and healthy tissues. It offers automatic, semi-automatic, and manual contouring of organs at risk and lymph nodes, saving time and improving precision in treatment planning. The software is meant for use by trained professionals in clinical settings.