FDA Radiology AI Devices

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.

TeraRecon Aorta.CT is a software that automatically segments and labels key anatomical landmarks of the aorta from contrast CT Angiography scans. It helps trained medical professionals by providing 3D visualizations and measurements to assist in patient management and procedure planning, without altering the original scan data or providing diagnosis.

Rapid Neuro3D is an AI-powered medical software that processes CT angiography scans to provide 3D and 2D visualizations of the brain's arterial blood vessels. It helps physicians confirm the presence or absence of identified lesions and assists in evaluation and treatment planning by simplifying image interpretation.

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.

ScreenDx is an AI-powered software device that analyzes lung CT scans to identify patterns suggestive of interstitial lung disease. It provides clinicians with a qualitative output to help refer patients who may benefit from further assessment of lung fibrosis, supplementing standard care workflows but not replacing diagnostic methods.

The Dental Cone-beam Computed Tomography (FinScan F350) is an imaging system designed for dental and maxillofacial diagnostic support. It uses cone-beam CT technology along with panoramic and cephalometric X-ray imaging to produce detailed images of the dento-maxillofacial and TMJ structures, aiding dentists and health professionals in diagnosis, including assessment of growth and maturity for orthodontic treatment.

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.

Brainomix 360 e-CTA is a software system used by trained medical professionals to analyze CT Angiography images of the brain. It processes these images to provide visualizations and quantitative measurements, such as vessel density asymmetry, specifically in the middle cerebral artery region. This helps clinicians assess cerebral blood vessel conditions and supports clinical decision-making for stroke and related conditions. The software uses AI/ML algorithms to improve vessel detection and image quality, and integrates with standard hospital imaging systems for ease of use.

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.