FDA Radiology AI Devices

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.

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is a whole-body multi-slice helical CT scanner. It captures high-quality cross-sectional volume images of whole organs in a single rotation. It includes advanced AI algorithms—AiCE for noise reduction using Deep Convolutional Neural Networks and FIRST iterative reconstruction to improve image quality and reduce radiation dose. It supports spectral imaging with rapid kV switching to differentiate material composition in tissues, aiding clinicians in diagnosis and treatment planning.

Deep Learning Image Reconstruction software by GE Healthcare is an AI-powered CT image reconstruction tool that uses a deep neural network to produce high-quality CT images for head, whole body, cardiac, and vascular scans. It improves image noise, contrast detectability, and spatial resolution, helping clinicians obtain clearer images from CT scans for accurate diagnosis and patient care.

The RTHawk HeartVista Cardiac Package is an advanced software system that works with 1.5T and 3.0T MRI scanners to acquire and display real-time and conventional cardiovascular magnetic resonance images. It enables clinicians to obtain detailed heart images quickly and accurately, incorporating automated tools to optimize cardiac scans and improve patient imaging workflows.

The Ventripoint Medical System Plus (VMS+) 3.0 is a software and hardware system that works as an adjunct to ultrasound imaging. It records and analyzes 2D ultrasound images to reconstruct a 3D model of the heart's four chambers, helping clinicians measure heart chamber volumes and ejection fractions. This aids in cardiac assessment by providing detailed and accurate cardiac volume measurements using advanced image analysis techniques.

The Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is an advanced CT scanner that captures high-resolution 3D images of the whole body. It uses an AI-based algorithm called AiCE (Advanced intelligent Clear-IQ Engine) to reduce image noise and enhance image quality, which helps clinicians detect details more clearly. This makes diagnoses more accurate and can potentially reduce patient radiation exposure.

The Aquilion ONE (TSX-305A/6) V8.9 with AiCE is a whole body multi-slice helical CT scanner designed to acquire high-quality cross-sectional images of the whole body, including the head. It uses an advanced AI-powered reconstruction algorithm called AiCE to reduce image noise and improve image quality, helping clinicians to perform more accurate and detailed imaging across multiple anatomical regions like abdomen, pelvis, lung, and cardiac areas.

Deep Learning Image Reconstruction by GE Medical Systems is a software option for CT scanners that uses a dedicated deep neural network to generate high-quality cross-sectional images of the head and whole body from X-ray transmission data. It improves image quality while maintaining noise performance and spatial resolution, supporting routine clinical workflows for head, whole body, cardiac, and vascular CT scans across all ages.