FDA Radiology AI Devices

The EPIQ Series Diagnostic Ultrasound System by Philips is an advanced ultrasound imaging device that uses AI-powered software to aid clinicians in semi-automated quantification of heart valve function, specifically assessing the tricuspid valve and mitral valve regurgitation. This helps improve accuracy and efficiency in diagnosing cardiac conditions by providing detailed measurements and flow analysis from 3D ultrasound images.

The Aplio i900/i800/i700 Diagnostic Ultrasound System, Software V7.0 by Canon Medical Systems Corporation is a high-quality ultrasound imaging device designed for use in diverse clinical applications, such as cardiac, abdominal, musculoskeletal, fetal, and small organs imaging. It provides advanced imaging modes including Doppler, Harmonic Imaging, Elastography, and AI-based improvements like Auto Plane Detection and Quick Strain to enhance workflow efficiency and diagnostic accuracy for clinicians.

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.

Sonio Detect is an AI-powered software designed to assist healthcare professionals during fetal ultrasound exams by automatically identifying various fetal anatomical views and structures, and verifying the quality and characteristics of these images in real-time. This helps ensure that ultrasound examinations are complete and meet established protocols, potentially improving accuracy and efficiency in prenatal care.

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 Voluson Signature 20 and Voluson Signature 18 are advanced diagnostic ultrasound systems designed primarily for general radiology and specialized OB/GYN use. They provide high-performance ultrasound imaging, including real-time 3D/4D acquisition and various Doppler imaging modes, to help clinicians visualize and analyze the human body and fluids. These systems support multiple clinical applications such as fetal imaging, abdominal, cardiac, vascular, musculoskeletal, and more, aiding in diagnosis and patient care in hospital or clinical settings.

LOGIQ E10 is a general-purpose diagnostic ultrasound imaging system designed for use by qualified physicians. It supports multiple ultrasound modes such as B-mode, Doppler imaging, harmonic imaging, elastography, and 3D/4D imaging, providing digital image acquisition and processing. The system includes AI-powered features like Auto Renal Measure Assistant and Auto Abdominal Color Assistant to assist clinicians by automating measurements and suggesting anatomical views, thus improving workflow efficiency and diagnostic accuracy.

The LOGIQ E10s and LOGIQ Fortis are advanced general-purpose diagnostic ultrasound systems designed for use by trained healthcare professionals. They provide high-resolution ultrasound imaging and measurements across a wide range of clinical applications, including obstetrics, abdominal, cardiac, vascular, musculoskeletal, and intraoperative imaging. The systems incorporate various imaging modes such as Doppler, elastography, 3D/4D imaging, and AI-powered assistant features to enhance workflow and diagnostic accuracy, thereby assisting clinicians in evaluating and analyzing human body structures and fluids effectively.

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.

Sonio Detect is a software tool that uses machine learning to help healthcare professionals during fetal ultrasound exams by automatically detecting views, anatomical structures, and verifying the quality of images in real-time. This supports sonographers and fetal specialists to ensure comprehensive and high-quality ultrasound examinations for fetuses from 11 to 37 weeks gestational age.