FDA Radiology AI Devices

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 Vantage Galan 3T, MRT-3020, V9.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system developed by Canon Medical Systems Corporation. It produces detailed cross-sectional images of the body and head using advanced AI-powered reconstruction techniques to enhance image quality, reduce artifacts, and improve workflow for clinicians. The device supports various deep learning-based features for motion correction, image resolution enhancement, noise reduction, and automated scan protocols, aiding diagnosis and patient care.

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.

The Vantage Galan 3T, MRT-3020, V8.0 with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system that produces detailed cross-sectional images of the head and body. It incorporates AI-powered image reconstruction (AiCE) and machine learning technologies to improve image quality, reduce artifacts, and assist in scan planning, helping clinicians obtain clearer and more precise diagnostic images efficiently.

The Aplio a550, a450, and a Diagnostic Ultrasound Systems from Canon Medical Systems Corporation provide high-quality ultrasound images in various modes including 2D, Doppler, Color Doppler, Elastography, and 3D/4D imaging. These systems support advanced features enhanced by artificial intelligence and machine learning to assist clinicians in diagnostics across multiple clinical applications such as fetal, abdominal, cardiac, vascular, musculoskeletal, and more.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V6.5 by Canon Medical Systems Corporation, is a high-quality diagnostic ultrasound system that provides detailed visualization of structures and dynamic processes in the human body. It supports multiple ultrasound modes and is suitable for use in hospitals and clinical settings, aiding clinicians in diagnosing conditions across areas including fetal, abdominal, cardiac, musculoskeletal, vascular, breast, and more.

The Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR is a 1.5 Tesla MRI system that produces detailed cross-sectional images of the body or head. It incorporates AI-based reconstruction and machine learning technologies to enhance image quality and assist in planning scans, improving diagnostic accuracy and patient comfort.