FDA Radiology AI Devices

The Vivid iq is a high-performance compact diagnostic ultrasound system made by GE Medical Systems Ultrasound. It supports a wide range of clinical applications including cardiovascular, abdominal, fetal, musculoskeletal, and more. The system enables automatic AI-based cardiac measurements and spectrum recognition to assist clinicians in analysis and diagnosis. It is intended for use by trained healthcare professionals in hospitals and private medical offices.

TOMTEC-ARENA is a clinical software package designed for reviewing, quantifying, and reporting medical imaging data primarily related to cardiovascular, fetal, and abdominal structures. It helps clinicians assess structures and functions from various imaging modalities in multiple dimensions, facilitating disease diagnosis through detailed quantifications and advanced visualization tools.

The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems specialized for cardiac imaging but also capable of vascular and general radiology applications. Featuring AI-driven tools for cardiac image analysis, these systems enable clinicians to perform automated measurements and enhanced visualization to improve efficiency and reduce variability. They support various clinical settings including hospitals and private offices with a range of imaging modes and transducers.

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.

The Vivid S60N and Vivid S70N are advanced general-purpose ultrasound imaging systems by GE Healthcare, specialized for cardiac imaging but also supporting a broad range of diagnostic ultrasound applications across the human body. These systems facilitate ultrasound imaging, measurement, display, and analysis to assist physicians in clinical environments such as hospitals and private offices, enhancing diagnostic accuracy and workflow efficiency through digital acquisition, processing, and semi-automated AI-based measurement features.

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.

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.

Syngo.CT CaScoring by Siemens is an AI-based software that evaluates non-contrasted cardiac CT images to identify and score calcified coronary lesions. It helps clinicians by automatically marking these lesions, assigning them to specific coronary arteries, and calculating clinically relevant scores such as the Agatston score, facilitating better assessment and documentation of coronary artery disease.

Caption Guidance is an AI-powered software that assists healthcare professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance similar to an expert sonographer, helping to capture standard echocardiographic views accurately and efficiently during 2D transthoracic echocardiography.