FDA Radiology AI Devices

The Aquilion ONE (TSX-305A/6) V8.9 with AiCE is a whole body multi-slice helical CT scanner designed to acquire high-quality cross-sectional images of the whole body, including the head. It uses an advanced AI-powered reconstruction algorithm called AiCE to reduce image noise and improve image quality, helping clinicians to perform more accurate and detailed imaging across multiple anatomical regions like abdomen, pelvis, lung, and cardiac areas.

Deep Learning Image Reconstruction by GE Medical Systems is a software option for CT scanners that uses a dedicated deep neural network to generate high-quality cross-sectional images of the head and whole body from X-ray transmission data. It improves image quality while maintaining noise performance and spatial resolution, supporting routine clinical workflows for head, whole body, cardiac, and vascular CT scans across all ages.

Bone VCAR is a software tool designed to assist clinicians in reviewing CT images that include the spine. It uses deep learning to automatically label vertebrae and provides optimized display settings to improve visualization and reporting efficiency across multiple care areas such as trauma and oncology.

HealthCCS is a software tool that uses cardiac CT images to automatically identify and measure calcified plaques in the coronary arteries. This helps physicians assess coronary artery disease risk by providing a calcium score and risk category report based on pre-existing CT scans, aiding further clinical decisions and patient management.

LungQ by Thirona Corporation is a software tool that processes CT chest scans to help physicians quantitatively analyze pulmonary tissues. It performs 3D segmentation of lung regions, volumetric and density evaluations, fissure analysis, and generates reports to support diagnosis and monitoring of lung conditions.

The Imbio CT Lung Density Analysis Software assists physicians by automatically processing CT scans of the lungs to quantify lung tissue density and identify abnormalities. It provides tools for 3D segmentation, volumetric analysis, and reporting, helping in diagnosis and monitoring of pulmonary conditions.

Hepatic VCAR is a software tool that analyzes CT scans of the liver to help clinicians visualize liver anatomy, detect and measure liver lesions, and assess liver morphology. It provides initial 3D segmentation and vessel analysis with tools allowing users to adjust and confirm segmentation, assisting in clinical review, archiving, and diagnosis related to liver conditions.