FDA Radiology AI Devices

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.

The TruSPECT Radiological Image Processing Station is a nuclear medicine imaging software system designed to process and display SPECT images alongside CT/MR scans for enhanced clinical diagnosis, including attenuation correction and quantitative assessment. It supports AI-based attenuation correction to improve image quality and aids clinicians, particularly for cardiac imaging and other clinical applications, by providing advanced visualization, segmentation, and quantitative tools.

ClariCT.AI is an AI-powered software solution that enhances the quality of CT images by reducing noise, especially in low-dose scans. This helps radiologists get clearer images to improve diagnosis while potentially lowering patient radiation exposure. It is compatible with CT images from any manufacturer and integrates seamlessly with medical IT systems.

QMENTA Care Platform Family is a software system that helps hospitals and clinicians receive, store, and analyze medical images from CT, MRI, and PET/CT scans. It integrates multiple AI-powered applications to process these images, assisting doctors in diagnosing by providing advanced image analysis and organized data accessible over a network.

SubtleMR is a software tool that enhances MRI images by reducing noise or increasing sharpness using a convolutional neural network algorithm. It works with various MRI scans of the head, spine, neck, abdomen, pelvis, prostate, breast, and musculoskeletal areas to help radiologists obtain clearer images for better interpretation and diagnosis.

QUIBIM Precision Prostate (qp-Prostate) is software designed to assist trained professionals such as radiologists in viewing and analyzing prostate MRI scans. It offers advanced post-processing features to quantify diffusion and perfusion characteristics, helping clinicians better visualize prostate tissue and complete structured reports. This software enables improved image analysis and decision support without performing a direct diagnostic function.