FDA Radiology AI Devices

syngo.via MI Workflows and syngo MBF are software applications by Siemens for advanced medical image processing and analysis. They work with various imaging modalities including PET, SPECT, CT, and MRI to help clinicians view, quantify, and compare images. The software supports disease management in oncology, cardiology, neurology, and organ function and also aids radiotherapy treatment planning.

WRDensity by Whiterabbit.ai is a software tool that uses deep learning to analyze digital mammography images and automatically assess breast tissue composition according to the ACR BI-RADS 5th Edition breast density categories. It helps radiologists by providing breast density categorization and probability scores, which can improve breast cancer risk assessment and patient management. The software works with various mammography systems and outputs results to PACS and RIS for clinician review.

LVivo Seamless is an AI software application that automatically analyzes echocardiogram ultrasound images to assess cardiac function by calculating parameters like ejection fraction (EF). It helps clinicians by streamlining the evaluation process, sending analyzed results directly to PACS for review, enhancing diagnostic efficiency and accuracy for patients with suspected cardiac disease.

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.

The Caption Interpretation Automated Ejection Fraction Software uses AI to analyze transthoracic cardiac ultrasound images and automatically estimate the left ventricular ejection fraction. This helps clinicians in cardiac evaluations by providing a consistent and efficient measurement of heart function, aiding diagnosis and treatment decisions.

Ezra Plexo Software is a medical imaging application designed to help radiologists view, manipulate, and compare 2D and 3D MR images through a web browser. It supports oncological workflows by enabling visualization, evaluation, quantification, and documentation of lesions, facilitating better clinical assessment and decision-making.

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.

MEDO ARIA is a cloud-based medical imaging software that uses machine learning to help clinicians view, quantify, and generate reports from ultrasound images of infant hips. It supports diagnosis of developmental hip dysplasia (DDH) in newborns and infants up to 12 months, assisting radiologists by automating some image analysis tasks and improving workflow efficiency.

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.

uWS-MR is a comprehensive medical imaging software that assists clinicians in viewing, manipulating, and analyzing MR images. It supports numerous advanced applications such as MR cardiac analysis, neuroimaging evaluation, spectroscopy, dynamic imaging, vessel analysis, and fusion of image series. It facilitates better interpretation and quantitative evaluation of various MR studies to aid diagnostic and clinical decision-making.