FDA Radiology AI Devices

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.

Al-Rad Companion (Musculoskeletal) is AI-powered software designed to analyze CT images of the spine. It supports clinicians by automatically segmenting and labeling vertebrae, measuring vertebral heights, and calculating the mean Hounsfield unit values within vertebrae, aiding in musculoskeletal disease evaluation and assessment.

The SonoVision Ultrasound Imaging System is a general-purpose ultrasound device designed to help physicians visualize nerves, vascular structures, and other anatomical features, especially during spinal procedures. It uses a specialized ultrasound probe and advanced image processing software to provide real-time imaging assistance, enhancing the accuracy and safety of medical interventions.

Broncholab is a software tool that helps doctors analyze CT scans of the lungs by providing detailed quantitative information about lung volume, airway volume, lung density, and other pulmonary tissue characteristics. It assists in the diagnosis and follow-up of lung abnormalities by creating 3D models and measurements from CT images, supporting clinical decision-making.

icobrain-ctp is a software package designed to analyze CT perfusion scans of the brain. It processes imaging data to calculate brain tissue perfusion parameters and volumes affected by abnormalities, providing detailed reports to aid clinicians in stroke and brain blood flow assessment. The tool supports image export in DICOM format and integrates with standard radiological viewing platforms, helping healthcare professionals make informed decisions efficiently.

AccuContour is a standalone software designed for radiation oncology departments. It uses AI-based deep learning to automatically contour organs at risk on non-contrast CT images and to register multimodality medical images. This helps clinicians in treatment planning, evaluation, and adaptation, improving workflow efficiency and accuracy in radiation therapy.

ADAS 3D is a software application designed to help medical professionals visualize and analyze 3D cardiac images obtained from MRI and CT scans. It supports the quantification and visualization of myocardial scar and other cardiac features to assist clinical decision-making for patients with cardiovascular disease. The software enables detailed analysis of the heart's structure and enhancement patterns, facilitating better cardiovascular disease assessment.

QLAB Advanced Quantification Software is a tool designed to help clinicians view and measure ultrasound images, specifically focusing on analyzing the heart's right ventricle using advanced automatic segmentation and machine learning. It assists healthcare professionals by providing accurate measurements that improve cardiac assessments without manual contouring for most cases, making the diagnostic process faster and more reliable.

QyScore Software is an automated medical image processing software that analyzes brain MRI scans to segment and measure brain structures and lesions. It generates an electronic report and overlays segmentations on images, helping clinicians quantify brain volumes compared to a healthy reference population. This assists in assessment and monitoring of brain health in patients aged 20 to 90 years.

Icobrain is an AI software tool that helps clinicians automatically identify, label, and measure brain structures and abnormalities using MRI or CT images. It supports tracking changes in brain volumes over time, aiding diagnosis and monitoring of brain diseases such as dementia or traumatic brain injury.