FDA Radiology AI Devices

The syngo.CT Lung CAD by Siemens Healthcare GmbH is a software tool designed to assist radiologists in detecting solid and subsolid lung nodules on chest CT scans. It uses advanced AI algorithms based on convolutional neural networks to highlight suspicious areas, reducing the chance of missed nodules. The software integrates with existing medical imaging platforms, improving clinicians' efficiency and accuracy in lung nodule detection, a critical task in lung cancer screening and diagnosis.

The Aquilion ONE (TSX-306A/3) V10.4 with Spectral Imaging System is a whole-body CT scanner that can capture detailed cross-sectional volume images of organs in a single rotation. It uses advanced AI algorithms such as deep convolutional neural networks to improve image quality and reduce noise, helping clinicians to better visualize anatomy and potentially optimize iodinated contrast media use. The spectral imaging system acquires images at different energy levels nearly simultaneously to differentiate tissues and materials, assisting in diagnosis and treatment planning.

Viz ICH is an AI-powered software tool that analyzes non-contrast CT brain images to detect suspected intracranial hemorrhages. It sends notifications to neurovascular or neurosurgical specialists to facilitate earlier patient review and intervention. The software is integrated with a mobile application for previewing images and managing notifications, though image previewing is non-diagnostic and full diagnosis relies on standard clinical evaluation.

Imbio RV/LV Software is an AI-powered medical imaging tool that automatically measures the diameters of the right and left ventricles of the heart from CT pulmonary angiography scans. It provides annotated images and reports to assist physicians in evaluating heart function, supporting clinical decision-making as part of cardiac assessment workflows.

Optellum Virtual Nodule Clinic is an AI-powered software that helps medical professionals track, assess, and characterize pulmonary nodules detected incidentally in CT scans. It provides a malignancy likelihood score using a convolutional neural network to support clinical decision making, improving diagnostic accuracy and patient management workflows for lung nodules.

MaxFOV 2 is a software option for GE CT scanners that uses deep learning to extend the display field of view in CT images beyond the scanner's nominal field, providing improved visualization of patient anatomy, especially useful in radiation therapy planning and for large patients. This helps clinicians obtain more complete images for diagnosis and treatment planning when parts of the body are outside standard scan coverage.

NinesMeasure is a software tool designed to help trained radiologists measure the size of pulmonary nodules on adult thoracic CT scans. It uses artificial intelligence to automatically calculate long and short axis diameters of nodules, providing quantitative information for better assessment and tracking over time. This tool assists clinicians by streamlining nodule measurement, though it is not intended to replace full patient evaluation or diagnosis.

TruPlan is a medical software that helps doctors visualize and measure heart and vessel structures from CT scans to assist in planning the left atrial appendage closure procedure. It provides tools such as segmentation, 3D rendering, and simulated imaging views to support detailed anatomical assessment and device sizing for safe and effective treatment.

The uAI EasyTriage-Rib is a software tool that uses artificial intelligence to analyze CT chest images and help radiologists prioritize trauma cases with suspected multiple acute rib fractures. It assists in workflow triage by flagging cases with suspected findings, allowing faster and more efficient patient management without altering the original medical images or making diagnoses itself.

ART-Plan is a medical software tool that helps clinicians plan radiation therapy for cancer patients. It supports image registration and fusion of CT, PET, and MRI scans to better visualize tumor and healthy tissues. It offers automatic, semi-automatic, and manual contouring of organs at risk and lymph nodes, saving time and improving precision in treatment planning. The software is meant for use by trained professionals in clinical settings.