FDA Radiology AI Devices

SERV MEDICAL CDSS is a medical image processing software designed for trained professionals, enabling viewing, processing, and analysis of imaging data acquired with Digital Subtraction Angiography (DSA). It helps clinicians visualize large vessels and supports clinical decision making by providing comprehensive image viewing and analysis capabilities on standard hardware.

The SIGNA Prime Elite is a whole body magnetic resonance imaging (MRI) scanner that offers high resolution and short scan times. It produces detailed images across multiple planes of the entire body, including the head, spine, heart, and musculoskeletal regions, assisting physicians in diagnostic interpretation to support detection and evaluation of various medical conditions.

PLANET Onco Dose (3.2) is a specialized software platform designed for medical professionals in molecular imaging and oncology. It helps manage and analyze various anatomical and functional medical images such as CT, MRI, SPECT, PET, and others. The software supports tumor and normal tissue segmentation, image co-registration, therapy response evaluation, and computes radiation doses at a voxel level for radionuclide-based therapies, improving treatment planning and patient care.

The BodyTom 64 is a computed tomography (CT) system designed for pediatric and adult imaging within an 85 cm aperture. It offers high-resolution CT scans with preset dose settings based on patient age and weight and can be used with or without contrast. The system is specifically intended for various diagnostic uses, including low dose lung cancer screening when used with established protocols. Its design includes a mobile gantry with a rotating disk x-ray generator and detector array, facilitating imaging at different clinical locations. The system includes an interventional radiology package that enhances clinical workflow and user experience.

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.

The 2430TCA with Xmaru W is a digital flat panel X-ray detector system designed for mammographic screening. It replaces traditional film or screen-based mammographic systems by capturing and digitizing high-quality breast images, assisting clinicians in breast cancer screening with enhanced image quality and reduced noise.

The RCT600 is a dental and maxillofacial imaging system that uses cone beam computed tomography (CBCT), panoramic, and cephalometric X-ray imaging to help dentists and healthcare professionals diagnose and plan treatment for both adult and pediatric patients. It produces high-quality 3D and 2D images of hard tissues like bones and teeth, as well as wrist images for orthodontic growth assessment, enabling better clinical decisions 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.

Cleerly LABS (v2.0) is a web-based software tool designed to help trained medical professionals analyze cardiac computed tomography (CT) images from Coronary CT Angiography (CCTA) scans. It uses machine learning to segment and label coronary arteries, assess plaques, stenosis, and vessel measurements, improving the efficiency and accuracy of coronary artery disease (CAD) assessment. The software enhances medical imaging workflows by automating complex, time-consuming tasks while providing interactive 2D and 3D visualizations.

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.