FDA Radiology AI Devices

The SIGNA 7.0T is a high-performance whole-body magnetic resonance imaging (MRI) system designed to produce high-resolution images with high signal-to-noise ratio and short scan times. It supports imaging of the head and extremities in multiple planes and includes AI-driven image reconstruction software called AIR Recon DL, which enhances image quality by improving signal-to-noise ratio and sharpness without compromising low contrast detectability. This aids clinicians by providing clearer images for more accurate diagnoses.

HYPER AiR is a software device that enhances PET images by using pre-trained neural networks integrated into the image reconstruction process. It helps radiologists and nuclear medicine physicians by reducing noise and improving image contrast in fluorodeoxyglucose (FDG) PET scans, thereby potentially improving diagnostic confidence.

Cartesion Prime (PCD-1000A/3) V10.8 is a diagnostic imaging system that combines Positron Emission Tomography (PET) and multi-slice Computed Tomography (CT). It provides fused images to help clinicians assess metabolic and functional information for evaluating oncological, cardiovascular, and neurological diseases. The device incorporates an AI algorithm called AiCE-i that improves PET image quality and reduces noise using deep learning methods, facilitating better diagnosis and treatment planning.

Preview Shoulder is a pre-operative planning software that helps orthopedic surgeons develop shoulder surgery plans by processing patient CT scans. The software reconstructs 3D models of the shoulder anatomy, allowing surgeons to digitally place implants and generate detailed surgical planning reports, thus aiding surgical preparation without providing diagnostic decisions.

The MAGNETOM Vida, MAGNETOM Sola, MAGNETOM Lumina, and MAGNETOM Altea are magnetic resonance imaging systems designed to produce detailed cross-sectional images and spectra of the head, body, and extremities. These systems aid clinicians in diagnosis by providing high-quality images and offer specialized features such as interventional imaging support and automated workflows, improving reproducibility and efficiency.

The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System is a whole-body CT scanner that can capture detailed cross-sectional volume images of organs in a single rotation. It uses advanced AI algorithms such as deep convolutional neural networks to improve image quality and reduce noise, helping clinicians to better visualize anatomy and potentially optimize iodinated contrast media use. The spectral imaging system acquires images at different energy levels nearly simultaneously to differentiate tissues and materials, assisting in diagnosis and treatment planning.

The Vantage Galan 3T, MRT-3020, V6.0 with AiCE Reconstruction Processing Unit for MR is an advanced 3 Tesla MRI system by Canon Medical Systems. It utilizes AI-based deep learning reconstruction to improve image quality across various anatomical regions. This helps clinicians by providing clearer, high-quality diagnostic images of the head, body, and multiple specific anatomical areas, improving diagnostic confidence without changing the existing hardware or basic MRI functions.

MaxFOV 2 is a software option for GE CT scanners that uses deep learning to extend the display field of view in CT images beyond the scanner's nominal field, providing improved visualization of patient anatomy, especially useful in radiation therapy planning and for large patients. This helps clinicians obtain more complete images for diagnosis and treatment planning when parts of the body are outside standard scan coverage.

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.