FDA Radiology AI Devices

AVIEW by Coreline Soft is a comprehensive medical imaging software that processes CT images of the lungs and heart. It helps physicians analyze lung tissue quantitatively, characterize lung nodules, evaluate coronary artery calcium, and monitor progression of lung disease. The software provides advanced segmentation, registration, quantitative metrics, and reporting tools, integrating AI techniques such as deep learning and CAD to enhance diagnostic support and workflow efficiency.

Syngo.via RT Image Suite is a medical imaging software tool that helps clinicians visualize and manipulate 3D and 4D images from multiple modalities like CT, PET, and MRI in preparation for radiation therapy treatments. It provides advanced contouring tools including AI-based automatic organ segmentation, multi-modality image fusion, and supports creating treatment plans to improve accuracy and efficiency in radiation therapy workflows.

Limbus Contour is a software tool that uses machine learning to automatically create contours of normal anatomical structures on CT and MRI images for use in radiation therapy planning. It helps trained clinicians by providing optimized contours that can be imported into treatment planning systems, improving efficiency and accuracy in defining healthy tissues.

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.

AI-Rad Companion Prostate MR is AI-powered image analysis software designed to assist radiologists in viewing, segmenting, and analyzing prostate MR images to support targeted MR-US fusion biopsies. It automates prostate gland segmentation, allows manual annotation of findings, calculates PSA density, and exports results for biopsy planning, improving workflow and biopsy accuracy for clinicians.

Contour ProtégéAI is a software tool designed to assist medical professionals by automatically creating anatomical contours on CT and MR medical images using machine learning. It supports applications such as adaptive therapy, radiation treatment planning, and management of patient images. The software requires manual review and editing of contours to ensure accuracy, improving clinical workflow efficiency and patient care.

LVivo Software Application is an AI-powered ultrasound image analysis platform that automatically calculates important medical parameters related to cardiac and bladder function. It helps clinicians assess heart ventricles and bladder volume using processed ultrasound images, thereby improving diagnostic efficiency and accuracy.

AI-Rad Companion Brain MR is a software tool that helps clinicians analyze and evaluate brain MRI scans. It automatically segments and measures various brain structures, compares them with data from healthy individuals, and presents this information in an easy-to-understand report. This aids in diagnosis and treatment planning for patients with neurological conditions.

The Auto 3D Bladder Volume Tool by Butterfly Network is a software application integrated with Butterfly Network ultrasound systems. It uses machine learning (U-Net convolutional neural network) to automatically segment and measure bladder volume from ultrasound images, providing clinicians with noninvasive quantitative data to support diagnosis in adult patients.

QLAB Advanced Quantification Software is a software application that assists clinicians by providing advanced tools to view and quantify ultrasound image data, specifically for cardiac assessment including mitral valve quantification, helping improve diagnosis and treatment planning.