FDA Radiology AI Devices

The Vantage Orian 1.5T, MRT-1550, V6.0 with AiCE Reconstruction Processing Unit is a 1.5 Tesla MRI system from Canon Medical Systems designed to produce detailed cross-sectional images of the head or body for diagnostic use. It includes AI-based image reconstruction technology (AiCE) that enhances image quality and processing for a variety of anatomical regions, helping clinicians make more accurate diagnoses.

The Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i is a computed tomography (CT) scanner designed for whole body imaging, including the head. It incorporates an AI-driven image reconstruction algorithm called AiCE-i that reduces image noise and improves image quality by using deep convolutional neural networks. This enhancement supports clinicians by providing clearer, more detailed images with potentially lower radiation dose, facilitating better diagnosis and patient care.

The Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i is a whole-body multi-slice helical CT scanner that acquires and displays cross-sectional volume images, including the head. It incorporates AiCE, an AI-based noise reduction algorithm using deep convolutional neural networks, to improve image quality and reduce noise in scans of the abdomen, pelvis, lung, extremities, head, and inner ear. This technology helps clinicians obtain clearer images at potentially lower radiation doses, facilitating better diagnostic accuracy.

Deep Learning Image Reconstruction for Gemstone Spectral Imaging by GE Medical Systems is an AI-powered CT image reconstruction method designed to produce high-quality cross-sectional CT images from dual-energy X-ray data. It is intended for whole body, vascular, and contrast-enhanced head CT applications, enhancing image quality with a deep neural network-based algorithm that improves low contrast detectability, noise reduction, and artifact suppression, supporting accurate and reliable diagnosis.

HealthJOINT is a software product that assists clinicians by using artificial intelligence to create 3D models of knee bones from standard 2D X-ray images. This helps surgeons with preoperative planning for knee surgeries by providing detailed anatomical landmarks and accurate bone reconstructions, improving clinical assessment and surgical preparation.

The SIGNA 7.0T is a high-performance whole-body MRI scanner designed by GE Healthcare to produce high-resolution images of the head and extremities. It supports multiple imaging techniques and pulse sequences to generate detailed anatomical, functional, spectroscopic, and vascular images. The device helps clinicians in diagnosis by delivering high signal-to-noise ratio images with shorter scan times, particularly enabled by its advanced 7.0 Tesla magnetic field strength and optimized hardware.

SIGNA Artist is a magnetic resonance imaging (MRI) scanner designed to produce high-resolution diagnostic images of the whole body. It supports multiple imaging planes and can generate a variety of images including axial, sagittal, coronal, spectroscopic, parametric maps, and dynamic images. The AIR Recon DL software feature enhances image quality by improving signal-to-noise ratio and sharpness, assisting clinicians in diagnosis through clearer MRI images.

The Vantage Orian 1.5T with AiCE Reconstruction Processing Unit for MR is a 1.5 Tesla MRI system from Canon that enhances image quality by using AI-powered noise reduction techniques. This advanced software algorithm uses deep learning to reduce thermal noise and improve signal clarity, especially in brain and knee imaging, helping clinicians obtain clearer and more diagnostically useful MRI images.

Deep Recon is an AI-powered image reconstruction software designed for CT scanners. It uses deep learning technology to produce clearer CT images with less noise and better low contrast detectability, helping clinicians get accurate diagnostic images while potentially reducing the radiation dose for patients. It supports scans of the head, chest, abdomen, cardiac, and vascular regions, and is integrated into specific United Imaging CT scanners.

The uMR 780 is a 3.0 Tesla MRI system designed to generate high-quality cross-sectional and spectroscopic images of the head, body, and extremities. It assists clinicians in diagnosing various conditions by providing detailed anatomical and functional images, with the option to use contrast agents. The latest version includes software enhancements such as new pulse sequences and AI-assisted image reconstruction methods, improving image quality and analysis.