FDA Radiology AI Devices

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.

The Aquilion Lightning (TSX-036A/7) V10.2 with AiCE-i is a computed tomography (CT) scanner designed for whole body imaging, including the head. It incorporates an AI-driven image reconstruction algorithm called AiCE-i that reduces image noise and improves image quality by using deep convolutional neural networks. This enhancement supports clinicians by providing clearer, more detailed images with potentially lower radiation dose, facilitating better diagnosis and patient care.

Deep Learning Image Reconstruction for Gemstone Spectral Imaging by GE Medical Systems is an AI-powered CT image reconstruction method designed to produce high-quality cross-sectional CT images from dual-energy X-ray data. It is intended for whole body, vascular, and contrast-enhanced head CT applications, enhancing image quality with a deep neural network-based algorithm that improves low contrast detectability, noise reduction, and artifact suppression, supporting accurate and reliable diagnosis.

The Aquilion Exceed LB (TSX-202A/3) V10.6 with AiCE-i is a whole-body multi-slice helical CT scanner that acquires and displays cross-sectional volume images, including the head. It incorporates AiCE, an AI-based noise reduction algorithm using deep convolutional neural networks, to improve image quality and reduce noise in scans of the abdomen, pelvis, lung, extremities, head, and inner ear. This technology helps clinicians obtain clearer images at potentially lower radiation doses, facilitating better diagnostic accuracy.

Revolution Ascend is a computed tomography (CT) scanner designed for head, whole body, cardiac and vascular imaging. It produces detailed cross-sectional images using X-ray data taken from multiple angles. The system incorporates advanced AI-enabled features like deep learning-based auto positioning and machine learning-enabled intelligent protocoling to improve workflow and image acquisition. It aids clinicians in diagnosis, treatment planning, and monitoring.

FastStroke, CT Perfusion 4D is a software package designed to aid clinicians in analyzing and visualizing CT scans, especially for stroke assessment. It processes and displays vascular and perfusion data from CT scans of the head and neck to help identify collateral vessels and perfusion abnormalities, assisting physicians in stroke evaluation and treatment planning.

VIDA|vision is an interactive imaging software that helps physicians analyze CT scans of the lungs. It uses deep learning algorithms to automatically segment lung regions and provides detailed quantitative analyses to assist in diagnosing and monitoring lung diseases such as lung cancer, COPD, and asthma. This software reconstructs two-dimensional CT images into 3D views and generates detailed reports, streamlining the workflow and reducing manual effort for clinicians.

Deep Recon is an AI-powered image reconstruction software designed for CT scanners. It uses deep learning technology to produce clearer CT images with less noise and better low contrast detectability, helping clinicians get accurate diagnostic images while potentially reducing the radiation dose for patients. It supports scans of the head, chest, abdomen, cardiac, and vascular regions, and is integrated into specific United Imaging CT scanners.

Syngo.CT CaScoring by Siemens is an AI-based software that evaluates non-contrasted cardiac CT images to identify and score calcified coronary lesions. It helps clinicians by automatically marking these lesions, assigning them to specific coronary arteries, and calculating clinically relevant scores such as the Agatston score, facilitating better assessment and documentation of coronary artery disease.

Hepatic VCAR is a medical software designed to assist clinicians in analyzing liver CT scans by providing automated and editable 3D segmentation of the liver, liver lesions, and hepatic artery. It uses deep learning algorithms to improve accuracy, helping to assess liver morphology and changes over time, thereby facilitating faster and more precise liver evaluations.