ASUS Ultrasound Imaging System (LU800 series)

The ASUS Ultrasound Imaging System (LU800 series) is a portable, software-based ultrasound imaging system that runs on commercial mobile devices (tablets/smartphones) and communicates wirelessly via Wi-Fi with handheld transducers. It is intended for use by qualified healthcare professionals to conduct diagnostic ultrasound imaging and fluid flow analysis across multiple clinical applications including fetal, abdominal, cardiac, musculoskeletal, and interventional guidance in physician offices, clinics, and hospitals.

The device employs five transducer types (linear, convex HD array, microconvex array, phased array, and endocavity array) that communicate wirelessly via IEEE 802.11 Wi-Fi to mobile devices or PCs. It operates in B mode, M mode, pulsed-wave Doppler, color Doppler, power Doppler, and combined modes (B+M, B+CD, B+PWD). The system uses a rechargeable lithium-ion battery, multichannel beamformer, prescan converter, and icon-based touch interface on commercial off-the-shelf devices.

The device was tested to AAMI/ANSI ES60601-1 (2012), IEC 60601-1-2 (2020), IEC 60601-1-6 (2020), IEC 60601-1-11, IEC 60601-1-12 (2014), IEC 60601-2-37 (2015), IEC 62133 (2012), IEC 62304 (2006), IEC 62366-1 (2015), ISO 10993 series (biocompatibility), ISO 14971 (risk management), ISO 13485 (quality systems), and AIUM/NEMA UD 2 and UD 3 (2004).

The ASUS LU800 series is substantially equivalent to the Leltek LU700 predicate device (K222365) because both use the same fundamental ultrasound technology, employ identical operating modes and transducer types, support wireless communication via Wi-Fi, are portable systems with rechargeable batteries, and comply with the same safety and performance standards. The new LU800 models are tested and compliant with acoustic output, biocompatibility, and disinfection standards with no pragmatic detriments, and no clinical testing was required.