FDA Radiology AI Devices

The Neuro.AI Algorithm by TeraRecon, Inc. is an AI-powered medical imaging software that analyzes brain perfusion images acquired via CT or MRI. It processes dynamic imaging data to generate detailed maps of brain tissue blood flow and vascular structures, helping trained medical professionals assess brain perfusion and vascular health efficiently. The software outputs detailed parametric maps and visualization aids to support clinical diagnosis without replacing physician judgment.

Quantib Prostate is advanced image post-processing software designed to assist trained medical professionals in analyzing prostate MRI scans. It provides tools for automatic and semi-automatic segmentation of the prostate, visualization of multiparametric MRI images, PI-RADS scoring, and lesion analysis. By combining multiple MRI sequences into a single view and supporting volume computations, it helps clinicians in the detailed interpretation of prostate imaging, potentially improving diagnostic accuracy.

Cleerly Labs v2.0 is a web-based software that assists trained medical professionals by analyzing coronary CT images to detect atherosclerosis and stenosis. It uses AI to segment and label coronary arteries, enhancing efficiency and accuracy in diagnosing coronary artery disease and supporting clinical decision making.

THINQ is a medical imaging software device designed to automatically segment, label, and measure volumes of brain structures from 3D T1-weighted MRI scans. It provides clinicians with visual and quantitative reports comparing brain volumes to reference data, helping in the assessment of neurological conditions by automating brain morphometry.

Xeleris V Processing and Review System is a nuclear medicine software platform that helps physicians process, review, and quantify medical images from nuclear medicine, PET, and associated CT or MR scans. It supports multiple clinical applications including detection of brain diseases, lung conditions, coronary artery disease, and bone metastases, using AI-based image analysis such as deep learning for automated segmentation to enhance workflow efficiency and accuracy.

AVA (Augmented Vascular Analysis) by See-Mode Technologies is a software that uses artificial intelligence to analyze vascular ultrasound images from carotid and lower limb arteries. It segments vessel walls, measures carotid intima-media thickness, reads Doppler velocities, and generates detailed vascular ultrasound reports to aid clinicians like physicians and medical technicians in assessing cardiovascular health. The software runs on standard computers or cloud platforms and supports quality control by qualified clinicians to ensure accuracy.

AVIEW by Coreline Soft is a comprehensive medical imaging software that processes CT images of the lungs and heart. It helps physicians analyze lung tissue quantitatively, characterize lung nodules, evaluate coronary artery calcium, and monitor progression of lung disease. The software provides advanced segmentation, registration, quantitative metrics, and reporting tools, integrating AI techniques such as deep learning and CAD to enhance diagnostic support and workflow efficiency.

Limbus Contour is a software tool that uses machine learning to automatically create contours of normal anatomical structures on CT and MRI images for use in radiation therapy planning. It helps trained clinicians by providing optimized contours that can be imported into treatment planning systems, improving efficiency and accuracy in defining healthy tissues.

AI-Rad Companion Brain MR is a software tool that helps clinicians analyze and evaluate brain MRI scans. It automatically segments and measures various brain structures, compares them with data from healthy individuals, and presents this information in an easy-to-understand report. This aids in diagnosis and treatment planning for patients with neurological conditions.

icobrain-ctp is a software package designed to analyze CT perfusion scans of the brain. It processes imaging data to calculate brain tissue perfusion parameters and volumes affected by abnormalities, providing detailed reports to aid clinicians in stroke and brain blood flow assessment. The tool supports image export in DICOM format and integrates with standard radiological viewing platforms, helping healthcare professionals make informed decisions efficiently.