FDA Radiology AI Devices

Vivid Pioneer is an ultrasound imaging system using pulsed Doppler technology to help clinicians visualize and assess blood flow and cardiac function. It supports medical imaging and diagnosis, assisting healthcare professionals in evaluating patient health.

FETOLY-HEART is a software tool that helps healthcare professionals during fetal ultrasound exams by automatically detecting key fetal heart views and assessing the quality of those views in real-time. It supports clinicians in ensuring a complete and accurate fetal heart examination, particularly in the second and third trimesters of pregnancy, improving diagnostic confidence and workflow efficiency.

The EPIQ and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound imaging devices that include innovative AI-powered software features. The Smart View Select software automatically selects optimal heart images for analysis, while the Segmental Wall Motion software evaluates the movement of specific regions of the heart's left ventricle. These tools help clinicians perform more efficient and precise cardiac assessments, enhancing diagnosis and treatment planning.

The EPIQ Series and Affiniti Series Diagnostic Ultrasound Systems by Philips Ultrasound LLC are advanced ultrasound machines designed for diagnostic imaging and fluid flow analysis of the human body. They include a new AI-powered Smart Doppler View ID feature that automatically navigates and selects the appropriate Doppler measurement groups on the touchscreen interface, enhancing clinician workflow and reducing manual navigation during cardiac ultrasound exams. This helps clinicians focus on key Doppler measurements efficiently during cardiac assessments.

The 6440 MyLabX90 by Esaote is an advanced multifunctional ultrasound scanner that supports real-time imaging and analysis during diagnostic ultrasound procedures. It integrates AI features like automated endocardial border detection for cardiac function assessment and lesion contouring for breast exams, helping clinicians improve diagnostic accuracy and efficiency across multiple body regions.

The ACUSON Sequoia, Sequoia Select, and Origin are advanced multi-purpose diagnostic ultrasound systems by Siemens, designed for a wide range of clinical applications including fetal, abdominal, cardiac, vascular, and musculoskeletal imaging. They incorporate AI-based software applications (AI Measure, AI Assist, 2D HeartAI, 4D HeartAI) to assist clinicians in cardiac imaging by automating measurements, image annotation, and analysis, thereby improving workflow and diagnostic confidence.

The Philips Lumify Diagnostic Ultrasound System is a portable ultrasound device used by healthcare professionals to capture high-resolution ultrasound images and perform fluid flow analysis in various clinical applications including cardiac imaging. It incorporates an AI-based Auto EF Quantification feature that automatically assesses cardiac function by measuring the left ventricle’s ejection fraction, improving clinical workflows during cardiac examinations.

The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also applicable to vascular and general radiology. These systems use ultrasound technology to capture, process, and analyze images of the human body, aiding clinicians in precise measurements and display of ultrasound data. They include features such as 3D imaging, Doppler modes, and AI-assisted tools like Easy Auto EF and Easy AFI LV for enhanced image analysis, improving workflow and diagnostic accuracy for healthcare professionals.

The Vivid iq is a high-performance compact diagnostic ultrasound system designed for cardiovascular and shared service imaging. It assists healthcare professionals in ultrasound imaging, measurement, display, and analysis of human body and fluid, across a wide range of clinical applications including fetal, cardiac, abdominal, musculoskeletal, and vascular imaging. It incorporates advanced ultrasound modes such as Doppler, color Doppler, harmonic imaging, and real-time 3D imaging, supporting various transducers and enabling flexible clinical use in hospital and office environments.

The Vivid T8 and Vivid T9 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also supporting vascular and general radiology applications. They provide digital acquisition, processing, analysis, and image display, and incorporate AI algorithms such as Easy Auto EF and Easy AFI LV that assist clinicians by automating measurements and analysis of cardiac function, improving workflow and diagnostic accuracy.