FDA Radiology AI Devices

NeuroICH is a software tool designed to analyze non-contrast CT scans of the head using artificial intelligence to detect signs of intracranial hemorrhage. It provides notifications to specialist clinicians via a mobile app, helping to prioritize patient care without replacing standard diagnostic procedures.

The MEDRAD Centargo CT Injection System is an automated device used to inject contrast media and saline into patients during CT scans. It helps radiology professionals by providing controlled, precise, and programmable delivery of contrast agents, improving diagnostic imaging quality while ensuring patient safety through features like air detection and occlusion monitoring.

TeraRecon Cardiac.Chambers.MR is a software tool designed to automatically segment the anatomical structures of cardiac chambers from contrast or non-contrast cardiac MR scans in adult patients. It helps clinicians by providing precise delineation of the left and right ventricular walls, facilitating faster and more accurate cardiac assessment.

JLK-PWI is a software tool used by trained medical professionals to analyze special types of brain MRI scans called diffusion-weighted and perfusion-weighted images. It helps calculate parameters related to tissue water diffusion and blood flow, assisting clinicians in understanding brain tissue conditions. The software integrates with standard hospital imaging systems and allows for viewing and analysis, aiming to support diagnosis and treatment planning.

The Affera Integrated Mapping System with the Impedance Localization Patch Kit is a computer-based diagnostic tool designed to assist clinicians in catheter-based cardiac electrophysiological mapping. It provides real-time visualization of catheters, maps cardiac signals, and helps guide therapeutic interventions by displaying detailed cardiac maps and signals, enhancing cardiac procedure accuracy and patient care.

The Prophecy Surgical Planning System is a patient-specific surgical planning tool designed to aid orthopedic surgeons in total ankle replacement surgeries. It leverages medical imaging data from CT scans and X-rays to create customized 3D planning reports and guides that assist in the precise positioning and alignment of ankle implant components during surgery, improving surgical accuracy and patient outcomes.

The uDR 780i is a digital medical X-ray system designed for diagnostic imaging of various anatomical sites, including the skull, spinal column, chest, abdomen, and extremities. It supports examinations for both adult and pediatric patients in multiple positions. This system generates high-quality radiographic images that can be reviewed, stored, and shared via DICOM network, aiding clinicians in accurate and efficient diagnosis.

eRAD PACS is a software-only system that helps medical professionals receive, organize, store, and review medical images and clinical reports from various imaging modalities. It supports hospitals and imaging centers by providing access to diagnostic images and reports via web and custom interfaces, facilitating efficient image management and review for clinicians.

The Caduceus S is an augmented reality-based navigation system designed to assist surgeons in accurately placing pedicle screws during percutaneous spine surgery. It leverages intraoperative CT or 2D/3D C-arm imaging and optical tracking, projecting navigation data directly into a headset worn by the surgeon to improve precision and visualization during procedures involving the thoracic and lumbosacral spine.

The RemedyLogic AI MRI Lumbar Spine Reader is a software tool that automatically analyzes MRI images of the lumbar spine to identify and measure anatomical features. It helps radiologists and spine surgeons by providing quantitative measurements and image segmentations, which can improve the efficiency and accuracy of their analyses and reporting. Users review and adjust the software's outputs before finalizing diagnostic or treatment decisions.