FDA Radiology AI Devices

AiMIFY is a software that enhances contrast in brain MRI images after they have been taken, making lesions and other features easier for radiologists to see. It uses machine learning to improve image quality without requiring direct interaction with MRI machines, helping clinicians better identify abnormalities in the brain.

MICSI-RMT is a software medical device designed to improve head MRI images by reducing noise, enhancing image quality to assist radiologists. It processes functional and diffusion MRI images without a user interface, outputting enhanced images for better visualization of brain structures and activation maps, aiding in clinical MRI interpretation.

Syngo Carbon Enterprise Access (VA40A) is a software-only medical device developed by Siemens Healthcare GmbH for use in healthcare institutions. It provides an enterprise-wide web application to display and render DICOM and non-DICOM medical data, supporting image and result distribution for diagnostic use by trained medical professionals. The software facilitates standardized data access without controlling image acquisition and enhances clinical workflows with a user-friendly interface. It does not include automated diagnostic functions but supports quality display and management of medical images and documents.

SwiftMR is a software tool that automatically enhances MRI images by reducing noise and increasing sharpness using deep learning techniques. It integrates with medical imaging systems (PACS or MRI machines) to improve image quality, aiding radiologists and clinicians in better interpreting MRI scans.

SubtleMR (2.3.x) is an AI-powered software that improves MRI images by reducing noise or enhancing sharpness. It supports MRI scans of various body regions such as head, spine, abdomen, and more. This helps clinicians obtain clearer images, potentially improving diagnostic accuracy without additional scans or equipment.

Ezra Flash is a software tool that uses AI (convolutional neural networks) to enhance brain MRI images by reducing noise. It supports 3-Tesla Siemens and GE MRI scanners for specific sequences, providing clearer images to assist radiologists in diagnosis without altering the original images.

AIBOLIT 3D+ is a web-based software system that processes CT and MR medical images to create detailed 2D and 3D visualizations of anatomical structures. It assists healthcare professionals in surgical planning, training, and intraoperative reference by turning multi-dimensional images into easy-to-view and manipulate anatomical models, with color-coded organ identification to improve clinical decision-making.

SwiftMR is a software device that automatically enhances MRI images by reducing noise and increasing image sharpness using deep learning algorithms. It supports brain, spine, and musculoskeletal MRI images and integrates with existing PACS systems to improve diagnostic image quality without interrupting clinical workflow.

AIBOLIT 3D+ is a software system that takes CT scan images and processes them into detailed 3D visual models of anatomical structures. This tool helps doctors plan surgeries, train, and educate patients by enabling interactive viewing of organs and tissues from multiple angles and with enhanced clarity. It supports better decision-making and may reduce errors during procedures.

SwiftMR is a software medical device designed to automatically enhance brain MRI images by reducing noise and improving image sharpness. It processes MRI scans in DICOM format using advanced deep learning models, helping radiology professionals obtain clearer images for better diagnosis and clinical decision-making without interrupting their workflow.