FDA Radiology AI Devices

BoneMRI v1.6 is an AI-powered software that enhances MRI images to improve visualization of bone structures in the pelvic and lumbar spine regions. It uses advanced algorithms, including convolutional neural networks, to generate 3D images with enhanced bone contrast. This allows clinicians such as radiologists and orthopedic surgeons to better assess bone morphology and tissue density without the need for CT scans, improving diagnostic capabilities in these regions.

BoneMRI v1.4 is an image processing software that analyzes 3D gradient echo MRI scans to enhance visualization of bone structures in the pelvic and lumbar spine regions. It uses a convolutional neural network algorithm to generate images with improved bone contrast compared to surrounding soft tissue, helping clinicians better assess bone morphology and density without the need for CT scans. It is intended for use by radiologists and orthopedic surgeons to aid in image interpretation, but not for tumor diagnosis.

MI View&GO is a software application developed by Siemens for medical professionals to review, manipulate, and analyze medical images from modalities like PET, SPECT, CT, and MRI. It integrates molecular imaging with anatomical data to support disease management in oncology, cardiology, neurology, and organ function, and aids in radiotherapy planning. The software enhances image processing efficiency directly at the scanner console, allowing for timely quality assessment and basic reading of images.

EchoPAC Software Only / EchoPAC Plug-in is a software platform designed for diagnostic review, analysis, and reporting of ultrasound images. It allows post-processing of raw data from GE ultrasound scanners and DICOM ultrasound images, supporting multiple clinical applications like fetal, cardiac, abdominal, and musculoskeletal imaging. The software helps clinicians manage patient records and generate detailed reports efficiently.

BoneMRI is a software application that enhances MRI images to improve visualization of bone structures in the pelvic region, including the sacrum, hip bones, and femoral heads. It processes 3D MRI scans using a convolutional neural network algorithm to create enhanced images that help radiologists and orthopedic surgeons in assessing bone morphology and radiodensity without needing CT scans.

syngo.via MI Workflows and syngo MBF are software applications by Siemens for advanced medical image processing and analysis. They work with various imaging modalities including PET, SPECT, CT, and MRI to help clinicians view, quantify, and compare images. The software supports disease management in oncology, cardiology, neurology, and organ function and also aids radiotherapy treatment planning.

Ezra Plexo Software is a medical imaging application designed to help radiologists view, manipulate, and compare 2D and 3D MR images through a web browser. It supports oncological workflows by enabling visualization, evaluation, quantification, and documentation of lesions, facilitating better clinical assessment and decision-making.

uWS-MR is a comprehensive medical imaging software that assists clinicians in viewing, manipulating, and analyzing MR images. It supports numerous advanced applications such as MR cardiac analysis, neuroimaging evaluation, spectroscopy, dynamic imaging, vessel analysis, and fusion of image series. It facilitates better interpretation and quantitative evaluation of various MR studies to aid diagnostic and clinical decision-making.