FDA Radiology AI Devices

InVision Precision LVEF is a software tool that analyzes previously acquired transthoracic cardiac ultrasound images to automatically estimate the left ventricular ejection fraction, helping clinicians with cardiac evaluation. The software processes DICOM ultrasound videos, uses machine learning to segment the left ventricle, and allows clinicians to review and adjust the measurements for precise cardiac function assessment.

Us2.v2 is software that processes cardiac ultrasound images to automatically measure various heart structures and functions, helping clinicians analyze echocardiograms more efficiently and accurately. It supports qualified healthcare professionals by providing automated measurements of cardiac size and function, improving workflow and aiding diagnosis in adult patients.

AI Platform (AIP001) by Exo Inc is a software tool designed to help medical professionals assess ultrasound images of the heart and lungs in adult patients. It uses AI to detect and measure features of these images, aiding in quantification and reporting of important clinical parameters such as ejection fraction and lung artifacts, thus supporting diagnosis and treatment decisions in a clinical setting.

Clarius Bladder AI is a software application integrated into the Clarius Ultrasound Scanner system that uses artificial intelligence to assist healthcare professionals in semi-automatically measuring bladder volume using ultrasound images. It automates bladder detection and measurement in both sagittal and transverse views but allows users to manually adjust results, facilitating efficient and accurate bladder volume assessment in adult patients.

Sonix Health is a software product that assists clinicians in analyzing adult echocardiography ultrasound images. It uses artificial intelligence to automatically classify ultrasound views, segment anatomy, and perform semi-automated measurements, helping physicians quantify cardiac function more efficiently. The software generates reports based on B-mode, M-mode, and Doppler ultrasound images and supports manual verification and adjustment of AI results.

Bladder AI is a software designed to assist healthcare providers in measuring bladder volume from ultrasound images using machine learning. It supports image-based assessment, landmark placement, and report generation for patients aged 2 years and older, improving workflow efficiency and accuracy in bladder volume quantification.

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.

Clarius AI is software integrated with the Clarius Ultrasound Scanner that uses artificial intelligence to semi-automatically measure tendon thickness on ultrasound images of musculoskeletal structures such as the Achilles’ tendon and patellar tendon. It helps healthcare professionals by segmenting ultrasound images and automatically placing measurement calipers, streamlining the quantification process while allowing manual adjustment by trained clinicians.

EchoPAC Software Only / EchoPAC Plug-in is a software platform designed for diagnostic review, analysis, and reporting of ultrasound images. It allows post-processing of raw data from GE ultrasound scanners and DICOM ultrasound images, supporting multiple clinical applications like fetal, cardiac, abdominal, and musculoskeletal imaging. The software helps clinicians manage patient records and generate detailed reports efficiently.

Libby Echo:Prio is a software tool that processes DICOM-compliant cardiac ultrasound images to provide automated measurements and analysis of cardiac function, such as ejection fraction and heart rate. It supports cardiologists and sonographers by automating view classification, border segmentation, and generating quantification reports, thus aiding clinical decision-making in cardiac care.