FDA Radiology AI Devices

HealthCCSng is a software tool that uses artificial intelligence to automatically detect and measure calcified plaques in the coronary arteries from routine non-gated, non-contrast CT scans. It provides an exact calcium score and categorizes the amount of calcium present, with results integrated into the radiologist's workflow to assist in assessing risk for coronary artery disease.

The Aquilion Serve SP (TSX-307B/1) V1.3 is a multi-slice helical CT scanner that acquires and displays whole-body cross-sectional imaging volumes. It includes an AI-based noise reduction algorithm called AiCE (Advanced Intelligent Clear-IQ Engine) that enhances image quality by reducing noise using deep learning techniques. This helps clinicians obtain clearer diagnostic images for various applications including abdomen, pelvis, lung, cardiac, extremities, head, and inner ear imaging.

The iCAC Device is a software tool that analyzes routine chest CT scans to automatically detect and quantify coronary artery calcium, which helps physicians assess cardiovascular risk. It provides outputs such as calcium segmentation visualizations and quantitative calcium scores during standard clinical workflows, assisting physicians without replacing original reports or scans.

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.

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.

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.

Precise Position is an AI-enabled accessory for Philips Incisive CT systems that assists technologists in accurately positioning patients before CT scans. It uses a ceiling-mounted camera to detect patient orientation, determine the scan range, and automatically center the patient's anatomy. This reduces positioning time and enhances accuracy for head, chest, abdomen, and pelvic CT imaging, ultimately improving imaging workflow and patient comfort.

Syngo.CT CaScoring by Siemens is an AI-based software that evaluates non-contrasted cardiac CT images to identify and score calcified coronary lesions. It helps clinicians by automatically marking these lesions, assigning them to specific coronary arteries, and calculating clinically relevant scores such as the Agatston score, facilitating better assessment and documentation of coronary artery disease.

Auto Positioning is a feature for GE CT systems that streamlines and automates patient positioning for CT exams by using a 2D/3D video camera and AI (deep learning) to determine anatomical landmarks, patient orientation, and optimal table position. This helps technologists position patients accurately and safely, improving image quality and workflow efficiency.

syngo.CT CaScoring is a post-processing software that assists physicians in evaluating and documenting calcified coronary artery lesions using CT scans. It calculates detailed calcium scores for the coronary arteries and generates reports to aid in cardiac risk assessment, helping clinicians detect and quantify coronary artery disease.