TE Air Diagnostic Ultrasound System

The TE Air Diagnostic Ultrasound System is a general-purpose ultrasound device that acquires and displays diagnostic ultrasound images in multiple modes (B, M, PWD, Color Doppler, Power Doppler, Tissue Harmonic Imaging, and TDI). It consists of a software app installable on iOS or Android mobile devices (including Mindray's customized AirSight platform) plus wireless ultrasound probes. It is intended for use by qualified healthcare professionals in hospitals or clinics for imaging, measurement, and analysis of fetal, abdominal, pediatric, cardiac, vascular, and other anatomic structures across all patient populations.

The subject device has the same imaging modes, clinical indications, and acoustic power levels as the predicate TE Air (K240906). The key modification is the addition of AirSight, a customized Android platform composed of processor, memory, display, audio, wireless module, battery, and housing that functions like a mobile phone. The AirSight, ultrasound probe, and TE Air app together form the complete imaging system, whereas the predicate could use commercial iOS or Android devices. All other technological characteristics, including safety features and operating parameters, remain identical to the predicate.

AAMI/ANSI ES60601-1:2005/(R)2012 with amendments; IEC 60601-1-2 Edition 4.0; IEC TR 60601-4-2 Edition 1.0; IEC 60601-2-37 Edition 2.1; IEC 62304 Edition 1.1; ISO 14971 Third Edition; ISO 10993-1 Fifth Edition; IEC 62366-1:2015+AMD1:2020; and IEC 60601-1-6 Edition 3.2. The device was tested for acoustic output, biocompatibility, cleaning/disinfection effectiveness, and thermal, electrical, and mechanical safety.

The subject device is substantially equivalent because it maintains identical intended use, clinical indications, imaging modes, and acoustic power output as the predicate TE Air (K240906). The only material change is the addition of AirSight as an optional hardware platform alternative to commercial mobile devices; this change has passed related bench tests without introducing safety risks. Since the ultrasound functionality, imaging capabilities, and safety characteristics are unchanged and the new platform component undergoes equivalent testing and design controls, the device poses no new safety or effectiveness concerns compared to the legally marketed predicate.