FDA Radiology AI Devices

EchoPAC Software Only / EchoPAC Plug-in is a diagnostic ultrasound image analysis software by GE that enables physicians to view, post-process, measure, and analyze ultrasound images across many clinical applications including cardiac, fetal, abdominal, musculoskeletal, and vascular imaging. It incorporates AI-based features to semi-automate cardiac measurements and streamline image interpretation, helping clinicians obtain quantitative data more efficiently and accurately.

AVIEW LCS by Coreline Soft Co., Ltd. is a diagnostic software tool that reviews, analyzes, and reports on thoracic CT images to help clinicians characterize lung nodules. It automatically measures nodule size, volume, density, and growth over time, integrates with FDA-cleared CAD for nodule detection, and provides lung cancer risk scoring and standardized Lung-RADS categorization. This helps clinicians detect, monitor, and manage lung nodules more accurately and efficiently.

KOALA is an automated software that helps medical professionals analyze knee X-rays by measuring joint space width and identifying radiographic signs of osteoarthritis. It assists clinicians in evaluating knee health and aids diagnosis, improving efficiency and accuracy in managing osteoarthritis cases.

aBSI is a software-only medical device designed to quantitatively assess and analyze skeletal disease burden on bone scans from nuclear medicine imaging. It helps healthcare professionals by automatically detecting and quantifying lesions to support clinical decision-making, particularly in oncology, by measuring disease extent in the skeleton.

Quantitative Total Extensible Imaging (QTxI) is a software tool that helps medical professionals manage and evaluate digital medical images from CT and PET scans. It supports tasks such as storing, retrieving, and displaying images, as well as identifying and analyzing regions of interest (ROIs) in full or partial body scans with 3D visualization. This software aids clinicians by automating quantification and monitoring changes in imaging data to improve diagnostic and treatment decision workflows.

EchoMD Automated Ejection Fraction Software by Bay Labs, Inc. is an AI-powered tool that analyzes previously acquired cardiac ultrasound images to automatically calculate the left ventricular ejection fraction, assisting clinicians in cardiac evaluation by providing streamlined, automated measurements integrated with DICOM-compatible PACS systems.

The UNiD Spine Analyzer is a web-based software designed to help healthcare professionals view and measure spine-related images, and plan orthopedic surgeries. It assists with measurements, surgical planning including osteotomies, and templating implants, enabling surgeons to prepare and validate plans for patient-specific spine implants.

DeltaView Model 2.1 is a software tool that processes current and prior chest x-ray images of the same patient to create a difference image highlighting areas of change. This assists radiologists in detecting lung nodules that have changed over time, improving diagnostic accuracy without replacing the original x-ray images.