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.

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.

The Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter is a reprocessed ultrasound catheter designed for imaging inside the heart and great vessels of adult patients. It assists clinicians by providing intracardiac and intraluminal visualization using the ultrasound modality. The catheter is intended for imaging guidance during cardiac interventional procedures, improving visualization of cardiac anatomy and device placement without treatment delivery.

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.

Op.n Navigation by Ecential Robotics is a surgical navigation system designed to assist surgeons during spinal surgery. It uses intra-operative 3D imaging to help accurately position surgical instruments and implants like pedicle screws in the thoracolumbar spine. This technology improves surgical precision and patient outcomes by providing real-time navigation based on detailed imaging.

The SPINEART Navigation Instrument System is a surgical tool used in thoracolumbar spinal surgery to help surgeons accurately locate anatomical structures for the placement of spinal screws. It integrates with the eCential Op.n PERLA® TL Navigation System, which uses intraoperative 3D imaging, to improve surgical precision in both open and minimally invasive procedures.

The Intra-Operative Positioning System (IOPS®) is a surgical navigation tool that helps clinicians navigate catheters and guidewires during endovascular procedures. It uses pre-acquired 3D vascular imaging data combined with real-time electromagnetic tracking to display precise tip positioning, serving as an adjunct to fluoroscopy. This technology enhances procedural accuracy without making direct diagnoses.

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.