FDA Radiology AI Devices

The Aquilion Precision (TSX-304A/4) V10.10 with AiCE is a whole-body CT scanner with ultra-high resolution that uses advanced AI deep convolutional neural networks to reduce image noise and enhance image quality, particularly for abdominal, pelvic, lung, and cardiac scans. It helps clinicians obtain clearer, more detailed images while potentially reducing radiation dose, thereby improving diagnostic confidence and patient care.

AI-Rad Companion (Pulmonary) is AI-powered software that analyzes chest CT scans to help radiologists and clinicians identify and measure lung structures and lesions. It segments lungs and lung lobes, detects lung nodules, compares current images to prior scans for lesion follow-up, and quantifies pulmonary density. These features support the clinical assessment and monitoring of lung diseases, improving workflow efficiency and diagnostic accuracy.

Deep Learning Image Reconstruction by GE Healthcare is a software solution that uses a specialized deep neural network to reconstruct high-quality CT images from raw X-ray data. It produces images with less noise and improved image quality while maintaining low radiation dose. It supports head, whole body, cardiac, and vascular CT scans, helping clinicians obtain clearer images for diagnosis.

syngo.CT Extended Functionality is a software package that provides advanced visualization and measurement tools for medical images acquired from CT and potentially other modalities like MRI. It helps technicians and physicians perform qualitative and quantitative analysis of clinical imaging data to assist in diagnosis by creating detailed images and measurements using various specialized extensions.

The Aquilion ONE with Spectral Imaging System is a whole body multi-slice helical CT scanner that captures high-resolution cross-sectional images of organs like brain, heart, and pancreas. It employs advanced AI-based reconstruction (PIQE) to enhance image quality and reduce noise, especially for cardiac applications. The accompanying Vitrea Software Package provides advanced imaging analysis applications, including spectral CT analysis, coronary artery analysis, and visualization tools assisting clinicians in diagnosis and treatment planning.

The syngo.CT CaScoring software by Siemens is used to analyze non-contrast cardiac CT scans to detect and evaluate calcified lesions in coronary arteries. It calculates scores like the Agatston score, mass, and volume scores for different coronary arteries, helping physicians assess coronary artery disease and generate detailed reports to support patient management.

The Philips Incisive CT is an advanced whole-body computed tomography system used to acquire detailed images of the head, body, heart, and vascular structures. It helps clinicians diagnose various conditions and supports low-dose lung cancer screening, improving patient care by providing high-quality diagnostic images efficiently.

HealthOST is an AI-powered image processing software that analyzes CT scans of the spine to help clinicians detect and assess musculoskeletal diseases in patients aged 50 and older. It labels vertebrae, measures vertebral height loss, and calculates bone density using Hounsfield Units, providing quantitative data to aid diagnosis and treatment planning without replacing clinical judgment.

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.