FDA Radiology AI Devices

Radiomics App v1.0 by Microsoft is a software tool designed to help trained radiation oncologists, dosimetrists, and physicists create precise three-dimensional contours of tumors and healthy anatomical structures in CT and MRI scans. This assists in radiation treatment planning by providing optimized organ and tumor segmentation, supporting improved treatment evaluation and planning workflows.

NeuroQuant is an AI-powered software tool that automatically processes MRI brain scans to identify and measure various brain structures and lesions. It generates detailed visual and quantitative reports, helping clinicians by automating the manual work of brain segmentation and volume measurement, thus supporting diagnosis and monitoring of neurological conditions.

SIS Software is designed to help medical professionals such as surgeons, neurologists, and radiologists visualize and plan surgeries targeting brain structures, particularly the subthalamic nucleus. It uses machine learning and image processing to enhance standard MRI images and create patient-specific 3D models of brain anatomy, supporting safer and more precise stereotactic surgical procedures.

Quantib Brain 1.2 is a software tool that assists radiologists by automatically identifying and measuring different brain structures and white matter abnormalities from MRI scans. It provides visualizations and quantitative data to support evaluation and reporting, enabling better assessment of brain health over time by comparing multiple scans of the same patient.

Arterys Cardio DL is an AI-powered software that analyzes cardiovascular MRI scans to quantify blood flow and heart function. It helps cardiologists and radiologists by providing clinically relevant, reproducible quantitative data from MRI images, supporting clinical decision-making without giving direct medical advice.

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.