FDA Radiology AI Devices

BriefCase-Quantification is an AI-powered software that automatically measures brain midline shift in non-contrast head CT scans, assisting medical specialists by automating a typically manual measurement process. It provides quantitative analysis and comparative reports over time to help clinicians monitor patients, without altering original images or serving as a standalone diagnostic tool.

BriefCase-Quantification is an AI-powered radiological image management and processing software that analyzes contrast-enhanced CT images to measure the maximum axial diameter of the abdominal aorta. It assists trained medical specialists by providing preliminary measurements to help evaluate normal and aneurysmal abdominal aortas. The tool outputs annotated preview images, which serve as unofficial measurements to aid clinical review, with final decisions left to radiologists.

Contour ProtégéAI by MIM Software Inc. is a medical imaging software that assists trained medical professionals by automatically creating contours on CT and MR images using machine learning. It helps in radiation therapy by segmenting anatomical structures and specific tissues like the prostate and urethra from imaging data, improving efficiency and accuracy in treatment planning. The software works on multiple platforms and supports cloud or local deployment, allowing users to review and edit automated results for patient management and follow-up.

BriefCase-Triage by Aidoc Medical is an AI-powered software that analyzes CT pulmonary angiography images to detect suspected cases of Central Pulmonary Embolism. It provides notifications and low-quality preview images to assist trained clinicians in prioritizing urgent cases, helping speed up patient care without replacing the standard diagnostic process.

MeVis Liver Suite is a medical image analysis software designed to assist physicians, especially radiologists and surgeons, in evaluating the liver and its vascular anatomy using CT and MR images. It provides tools for manual and AI-based semi-automatic segmentation of abdominal organs, liver lesions, and vascular structures, supporting treatment planning and follow-up assessment for liver-related conditions. The software calculates volumes, visualizes 3D vascular tumor margins, and enables manual spatial registration of images, enhancing clinical workflow without replacing diagnostic workstations.

Rapid SDH is an AI-based software that helps radiologists prioritize and triage head CT scans by detecting suspected hemispheric subdural hemorrhage (SDH). It analyzes non-contrast head CT images in parallel with standard readings and provides timely notifications with preview images for informational use, assisting clinicians in workflow management to improve patient care.

SpotLight/SpotLight Duo (with DLIR option) is a CT scanner that produces cross-sectional images of the body, including cardiovascular and thoracic anatomies. It uses a dual-tube CT system and advanced deep learning reconstruction to enhance image quality while reducing noise. This helps clinicians obtain clearer diagnostic images for disease detection and therapy planning.

The NeuViz 128 Multi-Slice CT Scanner System by Neusoft Medical Systems is a CT scanner designed for whole body imaging, producing cross-sectional images to help clinicians diagnose various medical conditions. It incorporates advanced AI-powered reconstruction methods to reduce noise and enhance image quality, potentially lowering radiation dose for patients while improving diagnostic capabilities.

The EFAI NeuroSuite CT ICH Assessment System by Ever Fortune.AI is AI-based software that analyzes adult non-contrast head CT scans to detect signs of acute intracranial hemorrhage. It helps radiologists prioritize urgent cases by sending triage notifications to their imaging workstations, enabling faster clinical assessment. This tool supports but does not replace clinician review.

Brainomix 360 Triage LVO is an AI-powered software that analyzes CT angiogram images to detect suspected large vessel occlusions in the brain. It assists hospital clinicians by providing priority notifications and compressed image previews via a mobile app or web interface, helping specialists quickly identify and review critical cases in parallel with standard workflows. This tool supports faster triage but is not intended for diagnostic use on its own.