FDA Radiology AI Devices

Prostate MR AI (VA10A) is a plug-in AI software device designed to assist radiologists in interpreting prostate MRI scans. It automatically segments the prostate gland, detects suspicious lesions, and assigns scores to help radiologists identify and classify potential prostate cancer. This tool supports clinicians by augmenting their workflow and improving diagnostic accuracy.

Ceevra Reveal 3+ is a software medical device that processes 3D images from CT and MR scans, employing machine learning to generate segmentations of normal anatomy. It helps healthcare professionals in preoperative surgical planning and intraoperative visualization to improve patient management. The software runs on computers and mobile devices and provides interactive tools for clinicians to examine anatomical structures in detail.

JLK-SDH is an AI-powered software that analyzes non-contrast CT head images to detect suspected subdural hemorrhage (SDH). It assists radiologists by notifying them of potential cases in a parallel workflow to standard care, enabling quicker communication and prioritization for specialist review. This helps clinicians promptly identify and manage patients with SDH, improving workflow efficiency and potentially patient outcomes. The device is intended for notification purposes only and does not replace diagnostic evaluation.

HeartSee Cardiac P.E.T. Processing Software is a tool that helps trained clinicians analyze heart PET images to quantify blood flow and heart function. It provides detailed maps and measurements that assist in diagnosing coronary artery disease by measuring myocardial perfusion and coronary flow reserve. This enables better clinical interpretation and patient management based on quantitative PET imaging data.

The LVivo Software Application is an AI-based software platform that automatically analyzes ultrasound images, primarily of the heart's left and right ventricles, to evaluate cardiac function, and also measures bladder volume. It supports both global and segmental evaluation of cardiac structures, providing clinicians with valuable measurements like ejection fraction and myocardial strain, helping diagnose and monitor heart disease and other medical conditions.

Myomics is a software tool designed to assist clinicians in viewing, processing, and quantitatively analyzing cardiovascular magnetic resonance (MR) images. Using AI-powered algorithms, it helps in detailed assessment of heart structures and adjacent vessels to support diagnosis in adult patients based on images acquired from 3.0 T MR scanners.

The 16ch Flex SPEEDER Medium and Large 1.5T coils are receive-only, 16-channel phased array coils designed to be used with Canon 1.5T MRI systems. These coils help produce high-quality diagnostic images of general human anatomy, assisting clinicians in accurately interpreting MRI scans for patient diagnosis.

ChestView US is an AI software product that analyzes frontal and lateral chest X-rays to detect and mark suspicious areas such as lung nodules, pleural abnormalities, mediastinal/hilar abnormalities, and consolidations. It provides annotated images with highlighted regions to assist clinicians in reading chest radiographs, improving diagnostic accuracy as a concurrent reading aid.

aiCockpit AI Viewer is a stand-alone software for clinicians that allows viewing and interacting with medical images and AI annotations within a web browser. It supports various imaging manipulation tools and 3D rendering, helping radiologists review findings effectively by displaying images alongside clinical documents and reports.

The Ventripoint Medical System Plus (VMS+) 4.0 is a software and hardware system that works alongside ultrasound machines to create 3D heart chamber models from 2D ultrasound images. This helps clinicians measure volumes and ejection fractions of the left and right ventricles and atria, improving assessment of cardiac function. The system uses AI-based reconstruction algorithms and manual control point adjustments to ensure accurate 3D modeling, providing detailed volumetric data and clinical reports.