FDA Radiology AI Devices

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.

The Millipede 070 Aspiration Catheter and Perfuze Aspiration Tube Set are medical devices designed to assist in the revascularization of patients experiencing acute ischemic stroke caused by large vessel occlusions in the brain. The catheter is used alongside a compatible aspiration pump to remove blood clots from the affected neurovasculature, helping to restore blood flow. This device is intended for use within 8 hours of stroke symptom onset and for patients who have not responded to or are ineligible for thrombolytic drug therapy.

Loss of Pulse Detection is a software application from Fitbit designed to analyze pulse data collected by consumer wrist-worn devices to detect possible loss of pulse events. When such events are detected, it alerts the user with audio, visual, and haptic signals, and can prompt an emergency call if the user does not respond. This helps in early identification of critical cardiac events, improving patient safety by notifying potential emergencies.

Sonio Suspect is a cloud-based AI software designed to assist clinicians during or after fetal ultrasound examinations by automatically detecting and characterizing abnormal fetal findings. It helps healthcare professionals identify potential issues in fetal development, improving diagnostic accuracy and supporting better patient management decisions.

The NUSONO Handheld Ultrasound Scanner is a portable, software-driven ultrasound imaging system that interfaces wirelessly with mobile devices to provide high-resolution diagnostic imaging in various clinical applications. It supports multiple imaging modes, including B-mode, M-mode, Color Doppler, and Power Doppler, enabling healthcare professionals to effectively diagnose conditions across fetal, abdominal, pediatric, urology, gynecology, cardiac, and lung areas. By integrating with smartphones and tablets, it offers flexible, real-time imaging solutions for use in clinics, hospitals, and point-of-care settings, enhancing diagnostic confidence and accessibility.

AVIEW CAC is a software tool designed for healthcare professionals to analyze non-contrast, non-gated Chest CT scans and quantitatively evaluate calcified plaques in coronary arteries. It automatically calculates the Agatston score, segments and evaluates the coronary arteries, and provides risk stratification based on calcium score, gender, and age. It facilitates access to CT data on various platforms, helping clinicians assess coronary artery disease risk using existing CT images.