FDA Radiology AI Devices

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.

MRCAT brain is a software add-on for Philips Ingenia MR systems that generates CT-like images from MR scans to assist in radiation therapy treatment planning for brain tumor patients. It helps clinicians by providing detailed tissue density maps necessary for accurate radiation dose calculations without the need for a separate CT scan.

QyScore Software is an automated medical image processing software that analyzes brain MRI scans to segment and measure brain structures and lesions. It generates an electronic report and overlays segmentations on images, helping clinicians quantify brain volumes compared to a healthy reference population. This assists in assessment and monitoring of brain health in patients aged 20 to 90 years.

Icobrain is an AI software tool that helps clinicians automatically identify, label, and measure brain structures and abnormalities using MRI or CT images. It supports tracking changes in brain volumes over time, aiding diagnosis and monitoring of brain diseases such as dementia or traumatic brain injury.

RSI-MRI+ is software designed to assist clinicians by automatically processing diffusion-weighted and anatomical MRI images. It enhances the visibility of restricted diffusion areas, fuses these with anatomical images, and uses AI to segment and quantify the prostate, providing helpful reports. This helps radiologists and urologists more efficiently analyze prostate MRI data.

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.

SubtleMR is a software device that enhances MRI images by reducing noise or increasing image sharpness using a convolutional neural network algorithm. It supports MR images from 1.2, 1.5, and 3 Tesla scanners and helps radiologists by improving image quality without requiring a user interface. This enhancement assists clinicians in better visualization of anatomical details for diagnosis and treatment planning.

LiverMultiScan (LMSv3) is a software tool that helps clinicians analyze liver MRI scans. It produces detailed images and quantitative maps of liver tissue properties such as fat content, iron levels, and T1 relaxation times to assist in non-invasive liver evaluation. This software aids trained operators in generating reports that help medical professionals diagnose liver diseases more accurately and efficiently.

SIS Software version 3.3.0 is a medical imaging application that assists clinicians, including surgeons and neurologists, by enhancing and visualizing brain MRI images, specifically the subthalamic nucleus (STN). It uses AI and image processing techniques to create 3D models and supports image fusion and co-registration between MRI and CT scans to guide stereotactic surgical procedures more accurately.

The SIGNA Premier is a whole body magnetic resonance imaging (MRI) scanner designed to produce high-resolution and high signal-to-noise ratio images in short scan times. It supports imaging of multiple body regions including the head, spine, breast, heart, abdomen, and musculoskeletal system, and uses advanced software featuring deep learning algorithms to automate steps in brain MRI examinations, thereby helping clinicians improve workflow and diagnostic consistency.