FDA Radiology AI Devices

uAI Portal is a medical imaging software system developed by Shanghai United Imaging Intelligence Co., Ltd. It provides tools to view, manipulate, and evaluate CT angiography studies focused on vascular structures within various anatomical regions including lower extremities, head and neck, coronary arteries, pulmonary arteries, and aorta. The software uses AI-based segmentation algorithms to help clinicians analyze vessel structures accurately and efficiently, making it easier to interpret complex vascular imaging data and facilitating clinical decision-making.

Velacur is a portable ultrasound elastography device designed to assist clinicians in the assessment of liver diseases. It non-invasively measures liver tissue stiffness and fat content by analyzing shear wave speed and ultrasound attenuation, helping in the management of conditions such as hepatic steatosis. The device incorporates AI algorithms to improve image quality and accuracy of liver tissue characterization.

Imbio PHA (4.0.0) is a medical image processing software designed to measure the maximal diameters of the heart's right and left ventricles, the main pulmonary artery, and the ascending aorta from CT pulmonary angiography scans. It uses artificial intelligence to identify and measure these structures, providing annotated images and summary reports to assist clinicians in evaluating cardiovascular health.

NeuroQuant is an automated software device designed to help clinicians by providing automatic labeling, visualization, and volumetric measurement of brain structures and lesions from MRI scans. It enhances clinical workflow by delivering segmented images and morphometric reports that can be reviewed and compared to normative data, aiding in diagnosis and monitoring of neurological conditions.

qCT LN Quant is a software tool that helps radiologists track, assess, and quantify lung nodules seen in CT scans. It provides volumetric and diameter measurements of user-selected nodules, with 2D and 3D visualizations, and uses AI algorithms to assist in characterizing nodules including measurements like volume doubling time and density. It supports clinical decision-making with integrated risk calculators based on established lung nodule malignancy and management guidelines.

CoLumbo is a software tool that helps radiologists and spine surgeons analyze MRI images of the lumbar spine by automatically segmenting anatomical features and measuring spine structures. It identifies out-of-range measurements and assists users in documenting findings, streamlining the review and reporting process without making any medical diagnosis.

OptimMRI (v2) is a software application that processes MRI brain images to generate detailed 3D annotated models highlighting specific brain regions. It helps clinicians in planning neurosurgical procedures by localizing critical brain nuclei, thus supporting accurate functional planning and improving surgical outcomes.

The i2Contour by MRIMath LLC is a web-based AI-assisted software designed to semi-automatically segment and quantify glioblastoma tumors from MRI scans. It helps trained medical professionals by providing initial tumor contours which can be reviewed and manually adjusted, enabling accurate tumor volume assessments for patients with pathologically confirmed glioblastoma. This facilitates monitoring tumor progression or treatment response but is not intended for primary diagnosis.

CardIQ Suite is a non-invasive software tool that analyses 2D and 3D CT cardiac images to assist clinicians in visualizing and measuring heart structures and vessels. It provides calcium scoring to evaluate calcified plaques and uses deep learning algorithms to automate segmentation and labeling of heart and coronary arteries, improving diagnostic workflow for cardiovascular diseases.

Acorn 3D Software is an advanced medical imaging software that processes CT and CTA scans to visualize, segment, and create detailed 3D digital models of musculoskeletal and craniomaxillofacial anatomy, including spine regions. It offers machine learning-based automatic segmentation for certain vertebrae and semi-automatic/manual tools for other bones. Clinicians can use these digital models for measurement, treatment planning, and can also produce physical 3D printed replicas for diagnostic purposes, enhancing surgical planning and patient care.