FDA Radiology AI Devices

Vitrea CT VScore is a software application designed to aid medical professionals in visualizing, segmenting, and quantifying calcified lesions in ECG-gated cardiac CT images of patients aged 30 years or older. It provides calcium scoring and generates detailed reports to assist clinicians in cardiac imaging assessment.

The BodyTom 64 is a computed tomography (CT) system designed for pediatric and adult imaging within an 85 cm aperture. It offers high-resolution CT scans with preset dose settings based on patient age and weight and can be used with or without contrast. The system is specifically intended for various diagnostic uses, including low dose lung cancer screening when used with established protocols. Its design includes a mobile gantry with a rotating disk x-ray generator and detector array, facilitating imaging at different clinical locations. The system includes an interventional radiology package that enhances clinical workflow and user experience.

Brainomix 360 e-Lung is a software tool designed to assist physicians by providing automated, quantitative analysis of chest CT images. It offers 3D segmentation, volumetric measurements, and density evaluations of lung tissue to support diagnosis and longitudinal assessment of lung diseases, enhancing workflow efficiency and accuracy in radiological interpretation of CT thoracic scans.

The NAEOTOM Alpha series by Siemens is a computed tomography (CT) scanner system that produces detailed cross-sectional images using X-rays. These images aid clinicians in diagnosis, treatment, radiation therapy planning, and interventions, including low-dose lung cancer screening for high-risk populations. The system uses advanced software for image reconstruction and supports various post-processing applications to deliver clear and precise imaging for multiple clinical uses.

Bunkerhill AVC is a medical software designed to automatically detect and quantify calcium deposits on the aortic valve using non-contrast chest CT scans. It helps physicians by providing a region of interest and an estimated calcium score to assist during case review, improving the identification and assessment of aortic valve calcification in adult patients.

The uCT 550 is a computed tomography (CT) X-ray system designed to produce detailed cross-sectional images of the whole body, including head, neck, cardiac, and vascular regions. It uses advanced AI-based deep learning algorithms to enhance image quality, reduce noise, and allow for dose reduction. This system helps clinicians with better diagnostic imaging across multiple body regions with improved accuracy and efficiency.

The SpotLight/SpotLight Duo with Low Dose Lung Cancer Screening Option is a computed tomography (CT) X-ray system developed by Arineta Ltd. It produces detailed cross-sectional images of the body, especially of the cardiovascular and thoracic areas, enabling clinicians to screen and diagnose lung cancer using low-dose CT protocols. This device helps physicians detect lung nodules and other thoracic abnormalities with reduced radiation exposure, supporting effective lung cancer screening programs following clinical guidelines.

The uCT 780 is a computed tomography (CT) system designed to produce cross-sectional images of the body including head, neck, chest, cardiac and vascular regions. It offers advanced AI-driven image reconstruction to improve image quality and reduce radiation dose, supporting lung cancer screening and various diagnostic tasks. This helps clinicians obtain clearer images for diagnosis while lowering radiation exposure for patients.

syngo.CT Dual Energy is a post-processing software application for CT scans that uses dual-energy imaging techniques combining low and high energy X-ray spectra to enhance visualization of different materials in the body. It helps clinicians by providing advanced imaging features for better evaluation of anatomical structures and pathologies, including brain hemorrhage visualization, lung perfusion, kidney stone analysis, and more, improving diagnostic accuracy without requiring additional scans.

Aquilion ONE (TSX-308A/3) V1.5 is a whole-body multi-slice helical CT scanner capable of imaging entire organs in a single rotation. It uses AI-powered deep learning reconstruction and noise reduction algorithms to enhance image quality, reduce radiation dose, and minimize artifacts. This helps clinicians obtain clearer diagnostic images for various body regions including the head, chest, abdomen, pelvis, cardiac, extremities, and lungs, supporting better patient diagnosis and treatment planning.