FDA Radiology AI Devices

Definium Pace Select ET is a digital radiography system designed to produce detailed X-ray images of multiple body parts including the skull, spine, chest, abdomen, and extremities for patients of all ages. It features advanced motorized components for positioning and enhances image acquisition with options like image pasting to stitch sequential images, improving workflow and diagnostic capabilities. The system is intended for routine radiography exams and helps clinicians by providing high-quality digital X-ray images that can be easily reviewed and shared.

LungVision is an AI-powered software system that helps clinicians navigate tools within the lungs during procedures. It combines previously acquired 3D CT images with real-time fluoroscopic X-ray images to provide detailed guidance for targeting lung lesions, thus enhancing the precision of pulmonary interventions.

MuscleView is an AI-powered software that automatically segments muscles and bones in MRI scans of the lower limbs. It calculates useful metrics such as muscle and bone volume, fat infiltration, and asymmetry to assist physicians in analyzing musculoskeletal health. The segmentations need to be reviewed and edited by trained clinicians. This tool helps improve the efficiency and accuracy of muscle and bone analysis from MRI images but is not intended for diagnostic use of diseases.

The GM85 Digital Mobile X-ray Imaging System by Samsung Electronics is a mobile X-ray device designed to generate digital radiographic images of human anatomy. It uses advanced digital detectors and software for image processing and communication with hospital information systems, aiding clinicians in efficient and accurate imaging workflows.

The CAC (gated) Algorithm is a software medical device designed to automatically detect and quantify coronary artery calcium from non-contrast ECG-gated cardiac CT scans. It aids physicians by providing calcium segmentation and quantification information integrated into their workflow, helping assess coronary artery health.

Sourcerer is a software tool designed for neurologists and EEG technologists to visualize brain activity by integrating EEG data with MRI images. It helps localize sources of brain activity by projecting EEG signals onto an idealized head model, aiding in clinical diagnoses such as epilepsy evaluation.

JBS-LVO is an AI-powered radiological software tool designed to analyze CT angiograms of the brain to detect suspected large vessel occlusions (LVOs). It notifies neurovascular specialists quickly via mobile app notifications to aid in rapid patient triage, supporting timely treatment decisions. The software provides compressed preview images for informational purposes, while diagnosis is made by specialists reviewing full-resolution scans.

Encevis (2.1) is a software tool that assists neurologists by automatically analyzing EEG recordings to detect seizures, spikes, electrographic status epilepticus, and other brain activity patterns. It reduces artifacts in EEG data, provides quantitative measures like frequency bands and burst suppression, and displays alerts to support rapid clinical decision-making, especially in acute care settings.

uAI Easy Triage ICH is an AI-powered software designed to assist radiologists by analyzing non-contrast head CT images to detect suspected intracranial hemorrhage (ICH). It helps prioritize and triage cases by flagging images that show possible bleeding in the brain, ensuring faster notification and workflow efficiency in hospital settings.

EchoGo Heart Failure 2.0 is an AI-powered software tool that analyzes echocardiogram images of the heart's apical four-chamber view to support clinicians in detecting heart failure with preserved ejection fraction (HFpEF). It provides a diagnostic aid by outputting a classification and a confidence score, enhancing cardiovascular assessments and helping guide clinical decision-making.