FDA Radiology AI Devices

Quantib ND is a software application that automatically labels, visualizes, and measures volumes of brain structures and white matter abnormalities from MR brain scans. It helps radiologists by providing detailed quantitative data and visual segmentations to assist in assessing and tracking neurological conditions.

The Voluson S Series (including S6, S8, S8t, S10, and S10 Expert) by GE Healthcare is a general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It provides high-performance ultrasound imaging and analysis with a focus on real-time 3D/4D acquisition across multiple clinical applications such as obstetrics, abdominal, cardiac, vascular, and musculoskeletal imaging. The system supports a variety of probes and modes including Doppler imaging, elastography, and contrast imaging, helping clinicians visualize and measure various body tissues and fluids in a hospital or clinical setting.

The UNiD Spine Analyzer is a web-based software tool that helps surgeons and healthcare providers view and measure spine-related medical images, plan surgical procedures, and simulate surgical strategies. It incorporates machine learning predictive models to assist in preoperative planning and includes a database of implant templates to aid in selecting and placing surgical implants. The software enhances clinical decision-making by providing quantitative radiographic parameters and predictive outputs for spine surgery planning.

AIBOLIT 3D+ is a software system that takes CT scan images and processes them into detailed 3D visual models of anatomical structures. This tool helps doctors plan surgeries, train, and educate patients by enabling interactive viewing of organs and tissues from multiple angles and with enhanced clarity. It supports better decision-making and may reduce errors during procedures.

TOMTEC-ARENA is medical software designed to help clinicians review and quantify cardiovascular, fetal, and abdominal ultrasound images. It incorporates AI to provide semi-automated measurements, improving workflow efficiency while allowing users to edit or accept these measurements. This supports physicians in diagnosing suspected diseases by providing detailed and accurate imaging analysis.

LiverSmart is a software that automatically analyzes MRI images of the liver to measure both liver iron concentration and liver fat content. It processes images according to established protocols and generates a comprehensive report that assists clinicians in diagnosing and monitoring liver conditions such as iron overload and fatty liver disease, supporting treatment decisions and research.

BoneMRI is a software application that enhances MRI images to improve visualization of bone structures in the pelvic region, including the sacrum, hip bones, and femoral heads. It processes 3D MRI scans using a convolutional neural network algorithm to create enhanced images that help radiologists and orthopedic surgeons in assessing bone morphology and radiodensity without needing CT scans.

qXR-BT by Qure.ai Technologies is an AI-powered software designed to analyze chest X-ray images to help physicians confirm the position of breathing tubes. It generates secondary digital images with highlighted tube tips and anatomical landmarks, providing valuable adjunctive information during radiological assessment.

BU-CAD is a software application designed to assist physicians by analyzing breast ultrasound images to identify and evaluate soft tissue lesions suspicious for breast cancer. It highlights regions of interest and provides malignancy scores and BI-RADS classifications to support clinical decision-making. It also supports viewing of mammography images and includes tools for image adjustment and documentation, helping improve diagnostic accuracy and efficiency.

EchoGo Core (2.0) is an AI-powered software that analyzes ultrasound images of the heart (echocardiograms) to automatically quantify and report cardiac function metrics. It assists physicians by providing measurements like ejection fraction, ventricular volume, and strain, helping in cardiovascular diagnosis for adult patients.