FDA Radiology AI Devices

ClearRead CT CAC is software that helps physicians assess coronary artery calcification on non-contrast, non-gated chest CT scans. It automatically detects and quantifies calcified coronary lesions, providing an Agatston score and categorization to aid in cardiovascular risk assessment. This allows clinicians to efficiently obtain quantitative calcium scoring to help guide patient management, supplementing but not replacing clinical expert review.

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.

The Spectral CT 7500 RT is an advanced computed tomography (CT) system that uses dual-layer detector technology to acquire high and low energy X-ray data simultaneously. This allows it to generate detailed cross-sectional images and analyze the chemical composition of tissues and contrast agents. It supports applications in radiology, cardiology, oncology, and radiation therapy planning, helping clinicians visualize and assess anatomical and pathological structures more accurately.

The CAC (gated) Algorithm is a software medical device designed to automatically detect and quantify coronary artery calcium from non-contrast ECG-gated cardiac CT scans. It aids physicians by providing calcium segmentation and quantification information integrated into their workflow, helping assess coronary artery health.

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.

CardIQ Suite is a non-invasive software tool that analyses 2D and 3D CT cardiac images to assist clinicians in visualizing and measuring heart structures and vessels. It provides calcium scoring to evaluate calcified plaques and uses deep learning algorithms to automate segmentation and labeling of heart and coronary arteries, improving diagnostic workflow for cardiovascular diseases.

The CT 5300 by Philips Healthcare is an advanced computed tomography system designed to produce detailed cross-sectional images of the head, body, cardiac and vascular structures. It supports various CT applications including diagnostic and low-dose lung cancer screening. The system uses AI-enhanced image reconstruction to provide high quality images at reduced radiation dose, helping clinicians detect and analyze anatomical features and abnormalities.

True Enhance DL is a deep learning-based software from GE Healthcare Japan Corporation that enhances contrast in standard 120 kVp CT images of the body, making details clearer without requiring changes to acquisition parameters. It is intended to assist clinicians by providing improved image contrast to aid diagnosis and is suitable for patients of all ages.

The Aquilion ONE (TSX-308A/3) V1.4 with PIQE Reconstruction System is a multi-slice CT scanner that uses advanced AI-based deep learning reconstruction algorithms to improve image quality by enhancing spatial resolution and reducing noise. It can capture detailed cross-sectional volumes of the whole body including organs like the brain, heart, and pancreas in a single rotation, assisting physicians in diagnostic and specialized studies.

The NAEOTOM Alpha is a dual-source computed tomography (CT) scanner developed by Siemens Medical Solutions. It uses advanced photon-counting detector technology and incorporates AI-driven image reconstruction and post-processing software to produce highly detailed cross-sectional images. This device assists trained clinicians in diagnosing and treating patients, including applications like low-dose lung cancer screening in high-risk populations. It features enhanced workflow tools, integrated needle guidance for interventions, and supports sophisticated quantitative imaging techniques.