FDA Radiology AI Devices

TumorSight Viz is an automated radiological image processing software designed to assist clinicians by analyzing medical images for tumor-related information, potentially improving diagnosis and treatment planning for patients with tumors.

The syngo.via MI Workflows, including Scenium and syngo MBF, is a multi-modality software platform developed to assist healthcare professionals in viewing, manipulating, quantifying, and analyzing medical images from various imaging modalities, including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids physicians in radiotherapy treatment planning by harmonizing PET data and providing standardized analysis tools such as brain amyloid quantification.

The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is software that uses deep learning to analyze left-hand X-ray images in pediatric patients aged 2 to 16 years. It estimates bone age to assist pediatric radiologists in clinical decision-making. The system integrates with existing PACS workflows, providing bone age assessments to support but not replace radiologist interpretation.

LVivo IQS is an AI-powered platform designed to analyze ultrasound images of the heart, specifically providing real-time quality scoring of right ventricle images from the 4-chamber apical view. This software helps clinicians by automatically detecting, measuring, and calculating important cardiac parameters and providing feedback on image quality, enhancing the reliability and interpretability of ultrasound examinations.

Transpara Density 1.0.0 is an AI-powered software designed to assist healthcare professionals in assessing breast tissue composition from digital mammography and tomosynthesis images. It automatically calculates volumetric breast density, breast volume, and categorizes breast density according to ACR BI-RADS 5th Edition. This helps radiologists make informed decisions about breast cancer screening and diagnosis.

LVivo IQS is a software application that processes ultrasound images of the heart to detect, measure, and calculate key medical parameters for patients with suspected cardiac disease. It provides real-time quality score feedback on image quality, helping clinicians ensure the accuracy and usefulness of cardiac ultrasound scans, particularly the left ventricle function from the 4 chamber apical view. This tool assists clinicians by improving the reliability of echocardiographic assessments.

Saige-Density is a medical software that uses AI deep learning techniques to analyze digital mammograms, producing breast density categories based on ACR BI-RADS guidelines. It helps radiologists assess breast tissue composition by providing adjunctive information, improving breast cancer risk assessment and screening interpretation.

ClariSIGMAM is a software tool designed to automatically analyze digital mammograms to estimate breast density by calculating the ratio of fibroglandular tissue to the total breast area. It categorizes breast density using BI-RADS groups to assist radiologists in assessing breast tissue composition, providing adjunctive information to support interpretation but is not a diagnostic aid.

Change Healthcare Anatomical AI is a standalone software that uses AI algorithms to analyze CT and MR images, automatically identifying anatomical regions and creating detailed anatomic descriptors. This information helps clinicians and integrated healthcare systems quickly locate and categorize relevant images or studies without altering the original images.

PowerLook Density Assessment V4.0 is a software tool that analyzes synthetic 2D images from digital breast tomosynthesis exams to provide breast density categories using the ACR BI-RADS 5th Edition. This helps radiologists assess breast tissue composition as an adjunctive aid, improving breast cancer screening processes.