FDA Radiology AI Devices

V5med Lung AI is an AI-powered software that helps radiologists detect pulmonary nodules in chest CT images. It automatically analyzes scans and highlights areas with suspected nodules between 4 and 30 mm, acting as a supportive tool to improve accuracy and reduce missed findings. The system integrates easily with clinical imaging workflows and has been clinically validated to improve radiologist performance and reduce reading time.

Rayvolve LN is an AI-powered software that helps radiologists detect and highlight suspected pulmonary nodules on frontal chest X-rays. By serving as a second reader, it aids in reviewing digital radiographs for patients 18 years or older, enhancing diagnostic accuracy without replacing the original chest images.

Radlink GPS Pro Imaging is an advanced image processing software that assists orthopedic surgeons in hip procedures by measuring the acetabulum’s position relative to bone structures seen in radiological images. The software overlays digital annotations on images and offers measurement tools to help surgeons plan and execute hip, knee, and trauma component positioning more precisely, improving procedural accuracy and outcomes.

QP-Prostate® CAD is an artificial intelligence-based software that helps doctors detect and identify suspicious lesions in the prostate gland using bi-parametric prostate MRI. It highlights areas of concern on the images to assist physicians during their interpretation but should be used alongside other clinical information. It seamlessly integrates with existing DICOM imaging systems and PACS, improving the diagnostic workflow for prostate cancer detection.

The LVivo Software Application is an AI-based software platform that automates the analysis of ultrasound images, primarily to evaluate heart-left ventricle function and bladder volume. It helps clinicians by automatically detecting and calculating important medical parameters, improving diagnostic accuracy and efficiency in cardiology and related fields.

Ziehm Vision FD is a mobile fluoroscopic X-ray system designed to provide continuous and pulsed fluoroscopic imaging during diagnostic, interventional, and surgical procedures. It helps clinicians visualize complex anatomical structures such as vascular, cardiac, and neurologic areas in real-time to better localize and treat pathological regions, improving accuracy in surgical and critical care settings. The system offers high-resolution flat panel displays, motorized and manual movement axes for precise positioning, and supports multiple peripheral interfaces, enhancing surgical workflow and patient care.

Better Diagnostics Caries Assist (BDCA) Version 1.0 is an AI-powered software tool that helps dentists automatically identify and mark areas of tooth decay (caries) on dental x-rays (bitewing and periapical). It provides visual annotations to support the dentist's diagnosis, improving the accuracy and efficiency of caries detection but does not replace clinical judgment or complete review.

LVivo Seamless is a software platform designed to automatically process echocardiogram ultrasound images to detect, measure, and calculate important cardiac medical parameters. It helps clinicians by selecting the appropriate image clips and activating AI modules to evaluate ejection fraction (EF) and global longitudinal strain (GLS), improving workflow and providing quantitative cardiac function data for better diagnosis and monitoring.

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.

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.