FDA Radiology AI Devices

The LVivo Software Application is an AI-based software platform that automatically analyzes ultrasound images, primarily of the heart's left and right ventricles, to evaluate cardiac function, and also measures bladder volume. It supports both global and segmental evaluation of cardiac structures, providing clinicians with valuable measurements like ejection fraction and myocardial strain, helping diagnose and monitor heart disease and other medical conditions.

The Ventripoint Medical System Plus (VMS+) 4.0 is a software and hardware system that works alongside ultrasound machines to create 3D heart chamber models from 2D ultrasound images. This helps clinicians measure volumes and ejection fractions of the left and right ventricles and atria, improving assessment of cardiac function. The system uses AI-based reconstruction algorithms and manual control point adjustments to ensure accurate 3D modeling, providing detailed volumetric data and clinical reports.

Sonio Suspect is a cloud-based AI software designed to assist clinicians during or after fetal ultrasound examinations by automatically detecting and characterizing abnormal fetal findings. It helps healthcare professionals identify potential issues in fetal development, improving diagnostic accuracy and supporting better patient management decisions.

The NUSONO Handheld Ultrasound Scanner is a portable, software-driven ultrasound imaging system that interfaces wirelessly with mobile devices to provide high-resolution diagnostic imaging in various clinical applications. It supports multiple imaging modes, including B-mode, M-mode, Color Doppler, and Power Doppler, enabling healthcare professionals to effectively diagnose conditions across fetal, abdominal, pediatric, urology, gynecology, cardiac, and lung areas. By integrating with smartphones and tablets, it offers flexible, real-time imaging solutions for use in clinics, hospitals, and point-of-care settings, enhancing diagnostic confidence and accessibility.

The Acclarix AX8 and AX9 Series Diagnostic Ultrasound Systems by Edan Instruments are advanced ultrasound imaging devices used by clinicians for a wide range of clinical applications including abdominal, cardiac, musculoskeletal, and vascular imaging among others. These systems support multiple imaging modes such as B mode, Doppler, harmonic imaging, elastography, and contrast imaging, aiding healthcare professionals in acquiring and interpreting ultrasound data to diagnose and monitor patient conditions effectively.

The V8 Diagnostic Ultrasound System and its variants are advanced ultrasound imaging devices designed to capture and analyze ultrasound images, including 2D, Doppler modes, and 3D/4D images. They assist healthcare professionals in diagnosing a wide range of medical conditions across various body regions by providing real-time imaging and measurement capabilities with AI-supported features such as nerve tracking and cardiac strain analysis.

The Vivid iq is a high-performance compact diagnostic ultrasound system designed primarily for cardiovascular and shared services imaging, but also applicable to various clinical areas such as fetal, abdominal, pediatric, musculoskeletal, and vascular imaging. It supports multiple ultrasound modes including Doppler and real-time 3D imaging. The system aids healthcare professionals by providing advanced ultrasound imaging and analysis capabilities for better diagnosis and patient care.

The Vivid T9/Vivid T8 is a diagnostic ultrasound system primarily intended for cardiac imaging but also supports vascular and general radiology applications. It provides digital acquisition, processing, measurement, display, and analysis of ultrasound images using various transducers and imaging modes. The system supports a range of clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, helping healthcare professionals in hospitals and clinics obtain real-time detailed images for diagnostic purposes.

Ultrasound Workspace (UWS 6.0) is a clinical software package from Philips designed for analyzing and quantifying ultrasound images of cardiovascular, fetal, and abdominal structures. Using AI and machine learning, it supports physicians in diagnosing conditions by automating the measurement of heart functions, valve anatomy, and blood flow dynamics. This helps improve efficiency and accuracy in interpreting ultrasound exams, particularly in adult cardiac applications.

The EPIQ Series Diagnostic Ultrasound System and Affiniti Series Diagnostic Ultrasound System by Philips Ultrasound LLC are advanced diagnostic ultrasound devices that use AI-powered AutoMeasure V3 software to provide semi-automated 2D, Doppler, and M-mode measurements for adult echocardiography. These systems help healthcare professionals efficiently perform and analyze cardiac ultrasound exams, improving measurement accuracy and workflow in clinical environments such as hospitals and clinics.