FDA Radiology AI Devices

The Vantage Fortian/Orian 1.5T, MRT-1550, V9.0 is a 1.5 Tesla magnetic resonance imaging (MRI) system developed by Canon Medical Systems. It incorporates AI-based technologies in its reconstruction processing unit (AiCE) to improve image quality, reduce scan time, and assist operators. This system aids clinicians by producing high-resolution images of anatomical structures of the head and body, facilitating accurate diagnosis and efficient workflow.

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 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.

Aquilion Serve (TSX-307A/1) V1.3 is a whole-body multi-slice helical CT scanner that captures detailed cross-sectional volume images including the head. It incorporates AiCE, an AI-powered noise reduction algorithm using deep convolutional neural networks to improve image quality and reduce noise. This helps clinicians obtain clearer images for specialized studies across multiple anatomical regions, aiding diagnosis and treatment planning while potentially reducing radiation dose.

The XIDF-AWS801 Angio Workstation (Alphenix Workstation), V9.5, by Canon Medical Systems is a medical imaging system used alongside interventional angiography equipment. It provides 2D and 3D imaging to assist clinicians in visualizing blood vessels throughout the body during catheter procedures. The device incorporates AI deep learning software to improve the detection and stabilization of stent markers, enhancing image clarity and aiding in diagnosis and treatment planning.

The Cartesion Prime (PCD-1000A/3) V10.15 is a PET/CT emission computed tomography system designed for diagnostic imaging. It helps clinicians by producing high-quality fused metabolic and anatomical images through PET and CT scans, improved by AI-driven noise reduction and motion correction. This aids in the evaluation, diagnosis, and treatment planning of various diseases such as cancer, cardiovascular and neurological disorders.

The Aquilion Precision (TSX-304A/4) V10.14 with AiCE is an advanced whole-body CT scanner that leverages AI through deep convolutional neural networks to reduce image noise and improve image quality. It also uses an iterative reconstruction algorithm to reduce radiation dose while enhancing spatial resolution. This helps clinicians obtain clearer and more detailed images to support diagnosis and treatment planning across various body regions, including abdomen, chest, brain, and extremities.

The Aquilion Serve (TSX-307A/1) V1.2 with AiCE-i is a whole-body multi-slice helical CT scanner enhanced with AiCE, an AI-based noise reduction algorithm using deep convolutional neural networks. It improves image quality and reduces noise for abdomen, pelvis, lung, cardiac, extremities, head, and inner ear scans, helping clinicians obtain clearer diagnostic images faster and with potentially reduced radiation dose.

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.

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.