FDA Radiology AI Devices

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.

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.

PIUR tUS Infinity is a computer-aided detection system that assists medical professionals by analyzing ultrasound images of the thyroid and thyroid nodules. It uses AI and machine learning algorithms to create 3D volume reconstructions from 2D ultrasound images, allowing quantification and visualization of thyroid nodules to aid diagnosis. The system integrates seamlessly with FDA-cleared ultrasound equipment and produces reports to support clinical decisions.

CINA-CSpine by Avicenna.AI is a radiological computer-assisted triage and notification software that uses AI algorithms to analyze cervical spine CT scans for suspected acute fractures. It helps hospital networks and trained physicians by flagging potential fracture cases and prioritizing image review, enabling faster and more efficient diagnosis and patient care. It operates alongside the standard care workflow without altering original images, providing notifications with preview images for informational purposes.

Constellation (CON-001) is an automated software tool that processes whole-body MRI images to segment anatomical regions and quantify various tissues such as muscles, fat, and organs. It provides clinicians with detailed quantitative reports with visual overlays to support clinical decisions without making autonomous diagnoses, focusing on healthy adult patients.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 by Canon Medical Systems Corporation is a high-quality ultrasound imaging device designed for use in diverse clinical applications, such as cardiac, abdominal, musculoskeletal, fetal, and small organs imaging. It provides advanced imaging modes including Doppler, Harmonic Imaging, Elastography, and AI-based improvements like Auto Plane Detection and Quick Strain to enhance workflow efficiency and diagnostic accuracy for clinicians.

FETOLY-HEART is a software tool that helps healthcare professionals during fetal ultrasound exams by automatically detecting key fetal heart views and assessing the quality of those views in real-time. It supports clinicians in ensuring a complete and accurate fetal heart examination, particularly in the second and third trimesters of pregnancy, improving diagnostic confidence and workflow efficiency.

LumiNE US is a visualization software designed to help neurosurgeons and medical professionals prepare for surgery by converting 2D MRI and CT images into 3D models using AI-based segmentation. It enables visualization through augmented reality using head-mounted displays, assisting in understanding brain tumors and anatomy before surgery. The software is not intended for diagnostic use but to support surgical planning by providing enhanced image insights.