FDA Radiology AI Devices

The uMR Omega is a 3.0 Tesla superconducting MRI system designed to capture detailed anatomical and functional images of the head, body, and extremities. It supports various advanced imaging sequences and features, including new RF coils and enhanced image processing algorithms like SparkCo for artifact correction and Inline ECV for quantitative mapping. This device helps clinicians diagnose by providing high-quality images and assisting workflows such as breast biopsy and cardiac function analysis.

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.

QP-Prostate® CAD is an artificial intelligence-based software that helps doctors detect and identify suspicious lesions in the prostate gland using bi-parametric prostate MRI. It highlights areas of concern on the images to assist physicians during their interpretation but should be used alongside other clinical information. It seamlessly integrates with existing DICOM imaging systems and PACS, improving the diagnostic workflow for prostate cancer detection.

The SIGNA Prime Elite is a whole body magnetic resonance imaging (MRI) scanner that offers high resolution and short scan times. It produces detailed images across multiple planes of the entire body, including the head, spine, heart, and musculoskeletal regions, assisting physicians in diagnostic interpretation to support detection and evaluation of various medical conditions.

Prostate MR AI (VA10A) is a plug-in AI software device designed to assist radiologists in interpreting prostate MRI scans. It automatically segments the prostate gland, detects suspicious lesions, and assigns scores to help radiologists identify and classify potential prostate cancer. This tool supports clinicians by augmenting their workflow and improving diagnostic accuracy.

The 16ch Flex SPEEDER Medium and Large 1.5T coils are receive-only, 16-channel phased array coils designed to be used with Canon 1.5T MRI systems. These coils help produce high-quality diagnostic images of general human anatomy, assisting clinicians in accurately interpreting MRI scans for patient diagnosis.

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.