FDA Radiology AI Devices

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.

EdgeFlow UH10 is a handheld ultrasound device designed to noninvasively measure urine volume in the bladder. It uses deep learning AI to detect and outline the bladder in ultrasound images, calculates bladder volume, and displays results on its touchscreen. It supports both B-mode and harmonic imaging, helping healthcare professionals quickly assess bladder volume accurately and efficiently.

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 Aplio i900, i800, and i700 Software V8.1 Diagnostic Ultrasound System by Canon Medical Systems is an advanced ultrasound imaging platform. It provides high-quality ultrasound images across a variety of clinical applications, including fetal, abdominal, cardiac, musculoskeletal, and more. The system includes advanced imaging modes such as Doppler and elastography, and new AI-based features like Left Atrial Appendage analysis to improve diagnostic accuracy and workflow efficiency.

The Butterfly iQ3 Ultrasound System is a portable, hand-held ultrasound device used by trained healthcare professionals to capture diagnostic ultrasound images and measurements across multiple clinical areas such as cardiac, abdominal, lung, musculoskeletal, fetal/obstetric, and more. It offers various imaging modes and supports professional use in diverse healthcare environments, helping clinicians visualize anatomical structures and fluids for adult and pediatric patients.

The HM70 EVO Diagnostic Ultrasound System by Samsung Medison is a mobile, software-controlled ultrasound imaging device that captures detailed 2D, 3D, and Doppler ultrasound images across a variety of clinical applications such as obstetrics, cardiology, musculoskeletal, and dermatology. It includes advanced AI-powered features for tasks like nerve detection and uterus assistance to improve diagnostic accuracy, supporting clinicians in making informed patient care decisions.

LOGIQ Totus is a comprehensive diagnostic ultrasound system designed for use by trained healthcare professionals. It offers imaging, measurement, display, and analysis for a wide range of clinical applications, including obstetrics, abdominal, cardiac, vascular, and musculoskeletal imaging. The system supports multiple ultrasonic imaging modes and integrates AI-enabled features such as auto preset selection and auto abdominal color assistant to improve efficiency and accuracy in clinical settings.

The EPIQ Series Diagnostic Ultrasound System by Philips is a diagnostic ultrasound imaging device that provides detailed ultrasound images and fluid flow analysis to assist clinicians in diagnosing a wide range of medical conditions across multiple body regions. It supports advanced modes such as transesophageal cardiac imaging and works in different clinical environments including hospitals and clinics. The system integrates with Philips EchoNavigator to aid in cardiovascular interventions by providing live ultrasound and X-ray guidance, enhancing the precision of treatments.

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.

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.