FDA Radiology AI Devices

The SonoVision Ultrasound Imaging System is a general-purpose ultrasound device designed to help physicians visualize nerves, vascular structures, and other anatomical features, especially during spinal procedures. It uses a specialized ultrasound probe and advanced image processing software to provide real-time imaging assistance, enhancing the accuracy and safety of medical interventions.

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.

The Vantage Galan 3T with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system from Canon that uses deep convolutional neural networks to reduce thermal noise and improve image quality in MRI scans, particularly for brain and knee regions. This advanced software and hardware combination helps clinicians obtain clearer MRI images, enhancing diagnosis without increasing scan time or contrast use.

Transpara is an AI-powered software designed to assist physicians in interpreting full-field digital mammography and digital breast tomosynthesis exams. It highlights suspicious regions that may indicate breast cancer, providing scores that indicate the likelihood of malignancy. This helps radiologists improve detection accuracy and workflow efficiency while supporting clinical decisions during breast cancer screening.

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.

The Behold.ai Red Dot device is an AI-powered software platform that assists radiologists by automatically analyzing adult chest X-ray images to identify suspected pneumothorax cases. It integrates into clinical workflows by notifying radiologists through PACS or workstation systems to prioritize these cases for faster review. It is intended to support, but not replace, clinical decision-making.

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.

Densitas densityai is a software application that analyzes digital mammography and breast tomosynthesis images to automatically assess breast tissue density. It provides a Breast Density Grade according to the American College of Radiology's BI-RADS 5th Edition to assist physicians in evaluating breast composition. This adjunctive tool helps interpret breast density consistently and efficiently, enhancing clinical decision-making in breast cancer screening.