FDA Radiology AI Devices

Viz ICH is an AI-based software tool designed to analyze non-contrast CT scans of the brain for signs of intracranial hemorrhage (ICH). When the software detects suspected ICH, it sends notifications to neurovascular or neurosurgical specialists, helping speed up patient care by alerting clinicians early. The system includes a backend server for image processing and a mobile app for reviewing images in a non-diagnostic way for quick assessment and communication.

Al-Rad Companion (Musculoskeletal) is AI-powered software designed to analyze CT images of the spine. It supports clinicians by automatically segmenting and labeling vertebrae, measuring vertebral heights, and calculating the mean Hounsfield unit values within vertebrae, aiding in musculoskeletal disease evaluation and assessment.

syngo.CT Lung CAD is an AI-powered software tool that helps radiologists detect solid pulmonary nodules in chest CT scans. Acting as a second reader, it alerts clinicians to potential nodules that might have been overlooked during their initial review, thereby improving diagnostic accuracy and patient care.

Broncholab is a software tool that helps doctors analyze CT scans of the lungs by providing detailed quantitative information about lung volume, airway volume, lung density, and other pulmonary tissue characteristics. It assists in the diagnosis and follow-up of lung abnormalities by creating 3D models and measurements from CT images, supporting clinical decision-making.

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.

AccuContour is a standalone software designed for radiation oncology departments. It uses AI-based deep learning to automatically contour organs at risk on non-contrast CT images and to register multimodality medical images. This helps clinicians in treatment planning, evaluation, and adaptation, improving workflow efficiency and accuracy in radiation therapy.

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.