FDA Radiology AI Devices

CardIQ Suite is a non-invasive software that analyzes cardiac CT scans to visualize heart vessels, measure calcium deposits, and evaluate heart fat volume. It helps clinicians diagnose cardiovascular diseases, monitor disease progression, and plan treatment by providing detailed vessel measurements and calcium scoring from cardiac CT images.

Bunkerhill AVC is a medical software designed to automatically detect and quantify calcium deposits on the aortic valve using non-contrast chest CT scans. It helps physicians by providing a region of interest and an estimated calcium score to assist during case review, improving the identification and assessment of aortic valve calcification in adult patients.

The Gating Reflector Block is a reusable hardware accessory used during radiotherapy treatment and imaging to track patient respiratory motion. It helps monitor breathing patterns by reflecting infrared light detected by cameras in compatible radiation therapy and imaging systems, improving motion management during imaging or treatment delivery.

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.