FDA Radiology AI Devices

GBrain MRI by Galileo CDS, Inc is an AI-powered software designed to process MRI images automatically, helping radiologists interpret brain scans more efficiently.

Brainlab Elements (7.0) is a suite of medical imaging software applications that aid clinicians in planning cranial and extracranial surgical and radiotherapy treatments. It provides tools for image fusion (aligning different imaging datasets), angiographic image registration, contouring (outlining anatomical structures), fibertracking (visualizing brain white matter tracts from diffusion imaging), and functional MRI mapping. The device supports precise treatment planning by combining and analyzing various imaging data, helping clinicians visualize critical anatomical and functional areas without being used for diagnostic purposes.

Cirrus Resting State fMRI Software is a medical imaging software that processes resting state functional MRI data to generate brain maps showing motor, language, and vision networks. These maps assist clinicians such as surgeons and radiologists in visualizing functional areas of the brain non-invasively, aiding in pre-surgical planning and clinical decision-making.

GBrain MRI is a software tool that automatically segments, quantifies, and reports the volume of signal hyperintensities in brain MR FLAIR images. It helps radiologists by providing quantitative measurements to support the evaluation of brain MRI scans, enhancing clinical assessment without replacing the physician's judgment.

DeepFoqus-Accelerate is an AI-driven software solution designed to improve brain MRI scans by reconstructing accelerated MRI data up to 4 times faster, producing clinical-quality images from undersampled data. It helps radiologists and technologists by enhancing non-contrast brain MRI images from 1.5T or 3T Siemens and GE scanners, making MRI scanning more efficient while maintaining image quality.

Myomics is a software tool designed to assist clinicians in viewing, processing, and quantitatively analyzing cardiovascular magnetic resonance (MR) images. Using AI-powered algorithms, it helps in detailed assessment of heart structures and adjacent vessels to support diagnosis in adult patients based on images acquired from 3.0 T MR scanners.

ScanDiags Ortho L-Spine MR-Q is an AI-powered software tool that processes previously acquired lumbar spine MRI images to provide quantitative measurements of spinal anatomical structures such as vertebral bodies, intervertebral discs, neuroforamina, and thecal sacs. It utilizes deep learning algorithms for semi-automatic segmentation and measurements, allowing radiologists to review and adjust results. This tool helps clinicians save time and improve the accuracy of lumbar spine assessment without replacing their expert interpretation.

SubtleHD (1.x) is an AI-based image processing software designed to enhance MRI images from any body part. It improves image quality by reducing noise and increasing sharpness, helping radiologists obtain clearer images without changing the original scan process. This facilitates improved diagnostic confidence and visualization of anatomical structures.

Ezra Flash is a software device that improves the quality of MRI images of the head, abdomen, and pelvis by reducing noise using advanced neural network algorithms. It processes images from 1.5T and 3T Siemens and GE MRI scanners, helping clinicians get clearer images to support more accurate diagnoses without additional scanning time.

MSKai is a medical software that helps clinicians by automatically identifying, measuring, and reporting features of the lumbar spine from T2 weighted MRI images. It supports radiologists and spine surgeons by providing reliable, repeatable quantitative assessments that can be reviewed and confirmed for clinical use, improving workflow efficiency.