FDA Radiology AI Devices

CT CoPilot is an AI-powered software designed for automatic labeling, visualization, and volume measurement of brain structures from CT scans. It helps radiologists by automating the manual process of analyzing brain CT images, providing detailed segmentation and volumetric data to assist in clinical assessments and comparisons across multiple imaging sessions.

Icobrain is a software that automatically identifies and measures volumes of brain structures in MRI scans. It helps clinicians by automating the manual process of labeling and quantifying brain regions, supports analysis at single or multiple time points, and generates detailed reports with volumetric measures to assist in diagnosis and tracking of neurological conditions.

The LVivo Software Application is a medical software that analyzes echocardiographic ultrasound videos to automatically detect and measure the left ventricular wall and function of the heart. It helps clinicians assess cardiac function by calculating metrics like ejection fraction and myocardial strain, thus aiding in cardiac diagnosis and management.

Quantib Brain 1 is an AI-powered software tool that automatically labels and measures the volumes of brain structures from MRI scans. It helps radiologists by providing quantitative data and visualization of brain tissue and white matter abnormalities to support diagnosis and reporting.

Volpara Imaging Software is a medical imaging application designed to analyze digital mammography and tomosynthesis images. It generates detailed breast density maps and calculates volumetric breast density, helping healthcare professionals assess breast tissue composition. The software provides numerical breast density values and BI-RADS categories as adjunctive information, supporting the diagnostic process.

The Imbio CT Lung Density Analysis Software assists physicians by automatically processing CT scans of the lungs to quantify lung tissue density and identify abnormalities. It provides tools for 3D segmentation, volumetric analysis, and reporting, helping in diagnosis and monitoring of pulmonary conditions.

Hepatic VCAR is a software tool that analyzes CT scans of the liver to help clinicians visualize liver anatomy, detect and measure liver lesions, and assess liver morphology. It provides initial 3D segmentation and vessel analysis with tools allowing users to adjust and confirm segmentation, assisting in clinical review, archiving, and diagnosis related to liver conditions.

AlphaPoint Imaging Software is a tool that helps clinicians review and analyze CT chest images by providing segmentation and numerical analysis of tissue types. It assists in identifying different substances in the images and generates preliminary reports to support medical decision-making.