FDA Radiology AI Devices

Discover FDA-cleared medical imaging AI devices with clean summaries, company insights, and linked references. We help you quickly understand what's approved, who built it, and how it fits into the evolving landscape of radiology AI.

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.

FDA #
K170981
Product Code
LLZ

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.

FDA #
K162830
Product Code
LLZ

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.

FDA #
K163013
Product Code
LLZ

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.

FDA #
K161322
Product Code
LLZ

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.

FDA #
K161148
Product Code
LLZ

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.

FDA #
K153351
Product Code
LLZ

IB Neuro v1.0 is software that processes MRI data to create maps showing blood flow and volume in the brain. These maps help doctors evaluate brain perfusion and may assist in clinical decision-making. The software integrates easily with existing MRI systems and PACS to streamline the workflow for clinicians.

FDA #
K080762
Product Code
LNH
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