FDA Radiology AI Devices

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.

The Aquilion Prime SP V10.2 with AiCE-i is an advanced CT imaging system that uses artificial intelligence through Deep Convolutional Neural Networks to reduce image noise and improve image clarity. This system helps clinicians capture better quality whole-body CT scans, including the head, optimizing image quality and potentially reducing radiation dose for patients.

The Aquilion ONE (TSX-306A/3) V10.0 with Spectral Imaging System is a whole-body multi-slice helical CT scanner. It captures high-quality cross-sectional volume images of whole organs in a single rotation. It includes advanced AI algorithms—AiCE for noise reduction using Deep Convolutional Neural Networks and FIRST iterative reconstruction to improve image quality and reduce radiation dose. It supports spectral imaging with rapid kV switching to differentiate material composition in tissues, aiding clinicians in diagnosis and treatment planning.

Auto Positioning is a feature for GE CT systems that streamlines and automates patient positioning for CT exams by using a 2D/3D video camera and AI (deep learning) to determine anatomical landmarks, patient orientation, and optimal table position. This helps technologists position patients accurately and safely, improving image quality and workflow efficiency.

ADAS 3D is a software application designed to help medical professionals visualize and analyze 3D cardiac images obtained from MRI and CT scans. It supports the quantification and visualization of myocardial scar and other cardiac features to assist clinical decision-making for patients with cardiovascular disease. The software enables detailed analysis of the heart's structure and enhancement patterns, facilitating better cardiovascular disease assessment.

BriefCase by Aidoc Medical, Ltd. is an AI-powered radiological software that helps radiologists quickly identify head CTA images with suspected Large Vessel Occlusion. It provides notifications and compressed preview images in parallel to standard image interpretation to speed triage and prioritization, enhancing clinical workflow without replacing full diagnostic review.

syngo.CT CaScoring is a post-processing software that assists physicians in evaluating and documenting calcified coronary artery lesions using CT scans. It calculates detailed calcium scores for the coronary arteries and generates reports to aid in cardiac risk assessment, helping clinicians detect and quantify coronary artery disease.

Deep Learning Image Reconstruction software by GE Healthcare is an AI-powered CT image reconstruction tool that uses a deep neural network to produce high-quality CT images for head, whole body, cardiac, and vascular scans. It improves image noise, contrast detectability, and spatial resolution, helping clinicians obtain clearer images from CT scans for accurate diagnosis and patient care.

Cleerly Labs is a web-based software application that helps trained medical professionals view and analyze cardiac CT images, specifically from Coronary Computed Tomography Angiography (CCTA). It assists in identifying and measuring coronary artery plaques and stenosis to help evaluate coronary artery disease or suspected CAD, providing detailed visualizations and measurements to support clinical decision-making.

AI-Rad Companion (Cardiovascular) is an AI-powered software that analyzes previously acquired CT chest images to segment the heart and aorta, quantify coronary calcium, and measure aortic diameters. It assists clinicians by providing quantitative and qualitative cardiovascular assessments to support diagnosis and evaluation in emergency, specialty, and general practice care.