FDA Radiology AI Devices

syngo.CT Brain Hemorrhage by Siemens Medical Solutions is an AI-powered software that helps radiologists prioritize CT scans suspected of having intracranial or subarachnoid hemorrhages. It analyzes head CT images to flag cases for earlier review, improving workflow efficiency. This software is not for diagnosis but supports clinicians by highlighting urgent cases based on AI detection of hemorrhages.

AI-Rad Companion (Pulmonary) by Siemens Healthcare GmbH is software that uses machine learning and deep learning to analyze previously acquired chest CT scans. It helps radiologists and physicians segment lungs and lung lobes, identify and measure solid and sub-solid lung nodules, and track changes over time. This supports clinicians in assessing lung diseases, improving workflow efficiency and diagnostic accuracy.

CINA-ASPECTS is a computer-aided diagnosis software designed to assist clinicians in evaluating brain tissue abnormalities using CT scans. It automatically analyzes regions of the brain affected by ischemic stroke, computes a standardized ASPECT score, and provides visual and quantitative data to support timely and accurate diagnosis of early acute stroke injury.

CINA-iPE is an AI-powered software that analyzes contrast-enhanced CT scans (not dedicated CTPA) to help detect incidental pulmonary embolisms. It flags suspected positive cases in real-time to assist radiologists in prioritizing patients and improving workflow efficiency. It operates alongside standard care without altering original images and provides informative preview notifications but does not replace diagnostic review.

The iCAS-LV software from HighRAD Ltd. is an advanced image analysis tool that helps physicians visualize and evaluate liver lesions in CT scans. It uses interactive segmentation, automatic registration, and volume measurement to track lesions' size, shape, and changes over time, supporting clinical decision-making without replacing physician judgment.

inHEART Models is a suite of medical imaging software tools designed to assist physicians, cardiologists, and radiologists by automatically processing CT images to create 3D models of the heart. It uses AI for automatic segmentation and visualization, helping clinicians better interpret cardiac anatomy for diagnosis and treatment planning.

CT Cardiomegaly is a command-line software tool designed to automatically measure the cardiothoracic ratio from CT chest images. It uses machine learning algorithms to segment the heart and thoracic cavity and calculate both linear and area-based cardiothoracic ratios. This assists physicians in identifying cardiomegaly, providing quantitative measurements to support clinical decisions within healthcare settings.

The Revolution Ascend Sliding is a CT X-ray system designed to generate detailed cross-sectional images of the body, including head, whole body, cardiac, and vascular areas. Uniquely, it features a gantry mounted on a transporter allowing linear movement on rails, improving patient workflow by enabling imaging and treatment procedures in the same room without moving the patient. It supports a range of acquisition modes and image processing features to aid clinicians in diagnosis and therapy monitoring.

QOCA® image Smart RT Contouring System is an AI-powered post-processing software designed to automatically outline organs at risk on CT scans. This helps radiation oncology clinicians efficiently prepare treatment plans by providing accurate organ contours as input data for radiation therapy, improving workflow and precision in treatment delivery.

HealthFLD is an AI-powered software that analyzes CT images of the liver to provide clinicians with quantitative and qualitative measurements of liver attenuation, aiding the assessment of fatty liver disease. It processes both non-contrast and contrast CT scans for adult patients and outputs liver density metrics to support clinical decision-making.