FDA Radiology AI Devices

SubtleMR is a software device that enhances MRI images by reducing noise or increasing image sharpness using a convolutional neural network algorithm. It supports MR images from 1.2, 1.5, and 3 Tesla scanners and helps radiologists by improving image quality without requiring a user interface. This enhancement assists clinicians in better visualization of anatomical details for diagnosis and treatment planning.

SIS Software version 3.3.0 is a medical imaging application that assists clinicians, including surgeons and neurologists, by enhancing and visualizing brain MRI images, specifically the subthalamic nucleus (STN). It uses AI and image processing techniques to create 3D models and supports image fusion and co-registration between MRI and CT scans to guide stereotactic surgical procedures more accurately.

MRCP+ v1.0 is a standalone software device from Perspectum Diagnostics that assists trained operators in the quantitative, non-invasive assessment of the biliary system using MR imaging data. It automatically generates 3D models of the biliary tree, measures bile duct widths, detects regions of variation, and provides tools for segmentation and volumetric analysis. This helps radiologists and clinicians better visualize and evaluate hepatobiliary structures, potentially improving diagnosis and patient care in biliary system diseases.

Quantib ND is an AI-powered software that processes MRI brain scans to automatically identify and measure volumes of various brain structures and white matter hyperintensities. It provides 3D visualizations and quantitative data to assist medical professionals in evaluating brain images and supporting quantitative reporting, making brain MR image assessment more precise and efficient.

Quantib Brain is a software application that automatically labels, visualizes, and measures brain structures and white matter lesions on MRI scans. It helps trained medical professionals by providing quantitative information to assist in the evaluation and assessment of brain MR images, supporting more informed and quantitative reporting in clinical settings.

iQMR is a software package designed to enhance MRI images by reducing noise and improving image quality. It operates on a PC server connected to a network, receiving and transmitting MRI images in DICOM format. This helps medical professionals get clearer images for better diagnosis and analysis.

cNeuro cMRI is a software tool designed to automatically identify, label, quantify, and visualize brain structures from MRI scans. It helps medical professionals by automating manual processes in brain image analysis, improving efficiency in the assessment of brain volumes and abnormalities compared to a healthy reference population.

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.