FDA Radiology AI Devices

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 by Canon Medical Systems Corporation is a high-quality ultrasound imaging device designed for use in diverse clinical applications, such as cardiac, abdominal, musculoskeletal, fetal, and small organs imaging. It provides advanced imaging modes including Doppler, Harmonic Imaging, Elastography, and AI-based improvements like Auto Plane Detection and Quick Strain to enhance workflow efficiency and diagnostic accuracy for clinicians.

The Vantage Galan 3T, MRT-3020, V10.0 with AiCE Reconstruction Processing Unit for MR is a 3 Tesla MRI system produced by Canon Medical Systems Corporation. It provides high-quality cross-sectional images of anatomical structures in the head or body, including advanced imaging techniques such as non-contrast enhanced MRA and diffusion imaging. The AiCE Reconstruction Processing Unit uses AI to enhance and speed up the image reconstruction process, helping clinicians obtain clear and detailed MR images for diagnosis.

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 Aplio i900, i800, and i700 Software V8.1 Diagnostic Ultrasound System by Canon Medical Systems is an advanced ultrasound imaging platform. It provides high-quality ultrasound images across a variety of clinical applications, including fetal, abdominal, cardiac, musculoskeletal, and more. The system includes advanced imaging modes such as Doppler and elastography, and new AI-based features like Left Atrial Appendage analysis to improve diagnostic accuracy and workflow efficiency.

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 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.