TE Air Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Electronics Co., LtdThe 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.
Intended Use
TE Air Diagnostic Ultrasound System is applicable for adults, pregnant women, pediatric patients and neonates and intended for fetal, abdominal, pediatric, small organ, neonatal and adult cephalic, musculo-skeletal (conventional and superficial), thoracic/pleural (for detection of fluid and pleural motion/sliding), adult and pediatric cardiac, peripheral vessel and urology exams. It is a general purpose diagnostic ultrasound system for use by qualified healthcare professionals to image, measure, display, and analyze human body and fluid in hospitals or clinics.
Technology
The system is a software-controlled ultrasonic diagnostic system consisting of wireless probes and an app installed on iOS or Android mobile devices, including Mindray’s customized Android platform AirSight. It supports modes B, M, PWD, Color Doppler, Power Doppler, Combined modes, Tissue Harmonic Imaging, and TDI. It processes ultrasonic echoes to generate real-time images and Doppler flow information.
Performance
The device underwent non-clinical testing for acoustic output, biocompatibility, cleaning and disinfection, thermal, electrical and mechanical safety conforming to multiple international standards including IEC 60601-1, IEC 60601-2-37, ISO 10993-1, among others. It passed bench testing with no safety risks introduced by new features. No clinical studies were required to support equivalence.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/6/2025
4 months - 2
FDA Approval
5/30/2025
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