FDA Radiology AI Devices

syngo.CT Extended Functionality is a software suite from Siemens that provides advanced visualization tools for CT and possibly MRI medical images. It helps technicians and physicians perform qualitative and quantitative measurements, facilitates advanced clinical evaluations using various extensions, and supports processing to aid in diagnosis.

Quantib ND is a software application that automatically labels, visualizes, and measures volumes of brain structures and white matter abnormalities from MR brain scans. It helps radiologists by providing detailed quantitative data and visual segmentations to assist in assessing and tracking neurological conditions.

VBrain is a software tool that helps medical professionals in planning radiation therapy for brain tumors. It uses artificial intelligence, specifically deep learning neural networks, to automatically outline brain tumors and organs at risk on MRI scans of the brain. This assists clinicians by providing initial contours that they can review and adjust, improving workflow efficiency and accuracy in treatment planning.

RT-Mind-AI is a software tool designed to automatically segment organs-at-risk in non-contrast CT images for patients undergoing radiation therapy. It helps radiation oncologists by providing accurate anatomical contours that support treatment planning and evaluation, improving workflow and precision.

LVivo Seamless is an AI-powered software application that analyzes ultrasound (echocardiogram) images to automatically detect heart structures, measure ejection fraction (EF), and calculate global longitudinal strain (GLS), aiding clinicians in assessing cardiac function efficiently and accurately. It runs offline on a server in healthcare settings, accepts DICOM-format ultrasound clips from various vendors, and sends results to PACS for professional review.

Al-Rad Companion (Pulmonary) is an AI-powered software by Siemens that processes CT images of the lungs to assist clinicians in quantitatively and qualitatively analyzing lung diseases. It segments lungs and lobes, detects lung lesions and areas of abnormal tissue density, and provides measurements to support radiologists and physicians in emergency, specialty, and general care settings. This helps streamline and improve lung disease evaluation.

OnQ Neuro is an automated software device designed to analyze neurological MRI images, specifically for brain tumors. It performs automatic segmentation and quantification of tumor volumes and diffusion-weighted imaging data, helping clinicians assess tumor progression and treatment response more efficiently by providing quantitative and graphical image data that can be integrated into clinical workflows.

Advanced Algorithms for Treatment Management Applications (AATMA) is a software library that uses machine-learning convolutional neural networks to automatically segment medical images. It provides derived data sets for use in radiation therapy treatment planning, accessible via an API and intended to help clinicians efficiently generate and review treatment contours from imaging data.

FlightPlan for Liver is a post-processing software that helps physicians analyze 3D X-ray angiography images to visualize the liver's vasculature and identify arteries near hypervascular lesions. It incorporates AI algorithms, including deep learning-based liver segmentation, to support the planning of liver embolization procedures, improving physician workflow and precision in treatment planning.

Contour ProtégéAI is a software tool that assists trained medical professionals by automatically creating contours on CT and MR medical images using machine-learning algorithms. It helps in quantitative analysis, adaptive therapy, image segmentation of various anatomical regions including prostate via MR images, and supports radiation therapy treatment planning. The contours can be reviewed and edited with appropriate visualization software.