FDA Radiology AI Devices

The TE Air Diagnostic Ultrasound System is a portable, general-purpose ultrasound device that uses wireless-connected probes and a mobile app to capture and display ultrasound images and Doppler flow information. It is intended for use by trained healthcare professionals to perform real-time ultrasound imaging, measurement, and analysis across a variety of anatomical regions and clinical applications, including fetal, abdominal, cardiac, musculoskeletal, thoracic, vascular, and urology exams. The system supports multiple imaging modes such as B-mode, M-mode, color and power Doppler, and tissue harmonic imaging, facilitating detailed internal body visualization and aiding diagnosis in clinics and hospitals.

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 Diagnostic Ultrasound System MX6 series by Shenzhen Mindray Bio-medical Electronics Co., LTD is a general-purpose, software-controlled ultrasound imaging device for a wide range of clinical applications including adult, pediatric, and neonatal exams. It supports various ultrasound modes such as B-mode, Doppler, Color Doppler, 3D/4D imaging, elastography, and contrast imaging. This device aids healthcare professionals in capturing, measuring, and analyzing ultrasound images to support medical diagnosis across multiple body regions such as abdomen, obstetrics, gynecology, cardiac, and musculoskeletal systems.

The Resona A10S and related series are advanced diagnostic ultrasound systems used by healthcare professionals to acquire, display, and analyze ultrasound images and measurements of the human body. The system supports a wide range of ultrasound imaging modes and can be used in diverse clinical applications such as cardiac, abdominal, gynecologic, and musculoskeletal exams, thus aiding clinicians in diagnosis and patient care.

The TEX20 and TEX10 series Diagnostic Ultrasound Systems by Shenzhen Mindray are versatile, software-controlled ultrasound machines designed for imaging adults, pregnant women, pediatric patients, and neonates. They support multiple imaging modes such as B-mode, Doppler (including Color, Power, Pulsed Wave), 3D imaging, elastography, and contrast imaging, helping clinicians visualize and measure anatomical structures and blood flow across a wide range of body areas including ophthalmic, fetal, abdominal, cardiac, and musculoskeletal exams. These systems enhance diagnostic confidence and efficiency for healthcare providers through advanced imaging features and AI-assisted tools such as Smart Nerve, which assists in visualizing nerve plexuses for guidance.