FDA Radiology AI Devices

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.

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.

The SIGNA Premier by GE Healthcare is a whole-body magnetic resonance imaging (MRI) system designed to produce high-resolution diagnostic images of many body parts including the head, spine, joints, and heart. It incorporates a new AI-powered software feature called AIR Recon DL that improves image quality by enhancing signal-to-noise ratio and sharpness, while allowing for shorter scan times. This helps clinicians get clearer images faster, supporting better diagnosis and patient care.

The Vantage Galan 3T with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system from Canon that uses deep convolutional neural networks to reduce thermal noise and improve image quality in MRI scans, particularly for brain and knee regions. This advanced software and hardware combination helps clinicians obtain clearer MRI images, enhancing diagnosis without increasing scan time or contrast use.

The Aquilion Prime SP V10.2 with AiCE-i is an advanced CT imaging system that uses artificial intelligence through Deep Convolutional Neural Networks to reduce image noise and improve image clarity. This system helps clinicians capture better quality whole-body CT scans, including the head, optimizing image quality and potentially reducing radiation dose for patients.