FDA Radiology AI Devices

VitruvianScan (v1.0) by Perspectum Ltd is a software medical device designed to analyze MRI images to generate quantitative metrics and composite images for evaluating body fat and muscle composition. It assists trained healthcare professionals by providing non-invasive diagnostic information that supports clinical decisions regarding patient health and wellness.

The Versana Premier, Versana Premier Lotus, and LOGIQ F are diagnostic ultrasound systems intended for use by trained healthcare professionals. They provide ultrasound imaging, measurement, display, and analysis for various body regions and clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and more, helping clinicians visualize and diagnose conditions through advanced ultrasound technology.

MammoScreen BD is an AI-powered software that helps radiologists evaluate breast tissue density in mammograms and digital breast tomosynthesis. It provides breast density categories based on established ACR BI-RADS standards. The tool offers supplementary information to aid radiologists in assessing breast density, supporting better screening decisions for women aged 40 and older. It processes DICOM images and integrates with clinical systems to assist interpretation without replacing physician judgment.

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.

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.

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.

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.

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.

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.

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.