FDA Radiology AI Devices

CardIQ Suite by GE Medical Systems is a non-invasive software tool designed to analyze 2D and 3D cardiac CT images, helping clinicians visualize and measure cardiovascular anatomy, including vessels and chamber mobility. It uses advanced AI algorithms for automatic calcium scoring and labeling of calcified plaques, aiding in diagnosis and treatment planning of cardiovascular diseases like coronary artery disease. The software also facilitates tracking calcium progression and supports clinicians with integrated workflows for reviewing coronary CT angiography data effectively.

Deep Learning Image Reconstruction (DLIR) by GE Medical Systems is an AI-powered CT image reconstruction method that uses a deep neural network to produce high-quality cross-sectional images of the head and whole body. It supports multiple CT acquisition types and enhances image quality by reducing noise and artifacts, helping clinicians get clearer and more accurate imaging results.

The Revolution Ascend is a CT scanner designed to generate detailed cross-sectional images of various body parts including the head, whole body, cardiac, and vascular areas. It uses x-ray transmission data taken at different angles and planes. The device supports multiple acquisition modes and post-processing of images, aiding clinicians in diagnosing disease, trauma, and abnormalities, as well as planning and monitoring therapy.

syngo.CT Extended Functionality is a software suite from Siemens that provides advanced visualization tools for CT and possibly MRI medical images. It helps technicians and physicians perform qualitative and quantitative measurements, facilitates advanced clinical evaluations using various extensions, and supports processing to aid in diagnosis.

Precise Image is an AI-powered reconstruction software for computed tomography (CT) systems developed by Philips. It produces high-quality images with lower radiation dose and noise, improving the detectability of low contrast features. This helps clinicians obtain clearer diagnostic images from CT scans of the head, body, and vascular regions, enhancing patient safety by reducing radiation exposure while maintaining image quality.

Al-Rad Companion (Pulmonary) is an AI-powered software by Siemens that processes CT images of the lungs to assist clinicians in quantitatively and qualitatively analyzing lung diseases. It segments lungs and lobes, detects lung lesions and areas of abnormal tissue density, and provides measurements to support radiologists and physicians in emergency, specialty, and general care settings. This helps streamline and improve lung disease evaluation.

Deep Learning Image Reconstruction by GE Healthcare is a software that uses deep neural networks to reconstruct high-quality CT images from X-ray transmission data. It helps radiologists by producing images with improved noise reduction, spatial resolution, and artifact suppression, suitable for head, whole body, cardiac, and vascular CT scans at routine clinical throughput.

HealthCCSng is a software device that automatically analyzes non-cardiac-gated CT scans to estimate the amount of calcified plaque in coronary arteries, which can indicate coronary artery disease risk. It provides radiologists with calcium detection categories and annotated images to aid in clinical decision-making within their usual workflow.

The Aquilion Exceed LB is a whole-body multi-slice helical CT scanner that captures detailed cross-sectional images of the body, including the head. It incorporates AiCE, an AI-based noise reduction algorithm using deep convolutional neural networks, to improve image quality and reduce noise. This helps clinicians obtain clearer, more accurate diagnostic images for various body regions, including abdomen, pelvis, lung, cardiac, extremities, head, and inner ear.

The uCT ATLAS with uWS-CT-Dual Energy Analysis is a multi-slice CT scanner designed for producing cross-sectional images of the whole body and specific organs using advanced imaging technology. It features fast scanning with high spatial and temporal resolution, low radiation dose, and AI-based enhancements for image quality and patient positioning. Its dual energy analysis software helps differentiate tissue composition using CT images acquired at different energy levels, aiding diagnostic insights.