FDA Radiology AI Devices

The Voluson™ Performance 16 and Voluson™ Performance 18 are advanced diagnostic ultrasound systems designed for use by trained healthcare professionals to image, measure, display, and analyze human body structures and fluids. These systems support a wide range of clinical applications including fetal/obstetrics, abdominal, pediatric, small organ, cardiac, vascular, musculoskeletal, and more. They provide real-time 3D/4D imaging, various Doppler modes, elastography, and have integrated AI features to assist in analysis. These systems enhance clinicians' ability to perform ultrasound examinations efficiently and with high image quality, aiding patient diagnosis and care.

The Diagnostic Ultrasound System (including models Recho R9W, Recho R9, and others) by Shenzhen Mindray Bio-medical Electronics Co., Ltd. is a general-purpose, mobile ultrasound imaging system. It helps trained healthcare professionals acquire and display ultrasound images in multiple modes like B, M, Doppler, 3D/4D, elastography, and contrast imaging, aiding in the diagnosis and analysis of various body regions in adults, pediatric patients, pregnant women, and neonates.

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 Voluson Expert Series (including models 18, 20, and 22) by GE Healthcare is a range of advanced ultrasound imaging systems designed for use by trained healthcare professionals in hospitals and clinics. They provide high-performance real-time ultrasound imaging and analysis capabilities including 2D, 3D, 4D, color Doppler, power Doppler, pulse wave Doppler, harmonic imaging, elastography, and advanced AI-assisted software for obstetric and gynecologic assessments. This helps clinicians obtain detailed diagnostic images for fetal, abdominal, cardiac, musculoskeletal, and other clinical applications, supporting accurate diagnosis and patient care.

The V5 and H5 series diagnostic ultrasound systems from Samsung Medison are advanced ultrasound imaging devices that provide real-time images and Doppler analysis to assist healthcare professionals in clinical diagnosis across a broad range of applications including obstetrics, cardiology, musculoskeletal, and dermatology. These systems use AI-powered tools for tasks like view recognition, segmentation, and measurement, enhancing accuracy and efficiency in ultrasound examinations.

The HERA W9 and HERA W10 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound imaging devices used to visualize and analyze structures within the human body. They support diverse clinical applications including obstetrics, cardiology, abdominal imaging, and musculoskeletal imaging through multiple ultrasound modes such as 2D, Doppler, and 3D/4D. The systems incorporate AI technologies to assist clinicians in fetal biometry and cardiac view recognition, helping improve diagnostic accuracy and workflow efficiency.

The HERA Z20, R20, HERA Z30, R30 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a versatile ultrasound imaging system used by healthcare professionals to obtain and analyze ultrasound images and body fluids. It offers multiple imaging modes including 2D, Color Doppler, Power Doppler, M mode, Pulsed and Continuous Wave Doppler, Tissue Doppler Imaging, and advanced AI-based features such as BiometryAssist, HeartAssist, ViewAssist, and others to aid in image recognition, measurement, and workflow efficiency. It is intended for clinical use in various applications including fetal, abdominal, cardiac, musculoskeletal, and more.

The V8/XV8/XH8, V7/XV7/XH7, V6/XV6/XH6 Diagnostic Ultrasound System by Samsung Medison Co., Ltd. is a general-purpose diagnostic ultrasound system that acquires ultrasound data and displays it in multiple modes including 2D, Doppler, and 3D/4D. It helps healthcare professionals with imaging and fluid flow analysis across many clinical applications such as fetal, cardiac, abdominal, and musculoskeletal imaging. The system includes AI-based features such as NerveTrack for nerve segmentation, enhancing diagnostic capabilities.

Clarius OB AI is an AI-powered software integrated into the Clarius Ultrasound system that assists healthcare professionals in measuring fetal biometric parameters such as head circumference and femur length using ultrasound images. It automates the detection and measurement process, helping clinicians make accurate assessments during obstetric ultrasound examinations.

The RS85 Diagnostic Ultrasound System by Samsung Medison is a versatile diagnostic ultrasound device used in a variety of clinical applications such as obstetrics, abdominal, cardiac, musculoskeletal, and peripheral vessel imaging. It provides multiple imaging modes including 2D, Doppler, and 3D/4D imaging and incorporates AI technology for nerve detection and segmentation to aid clinicians in diagnosis and procedures. This system helps healthcare professionals obtain high-quality ultrasound images and quantitative analysis to improve patient care.