Wireless Probe Type Ultrasound Scanner

The Wireless Probe Type Ultrasound Scanner is a portable, software-based diagnostic ultrasound system that wirelessly connects ultrasound transducers to standard smartphones, tablets, or PCs via Wi-Fi to acquire and display real-time ultrasound images. It is intended for diagnostic ultrasound imaging and fluid flow analysis across multiple clinical applications including fetal, abdominal, cardiac, pediatric, musculoskeletal, and peripheral vessel imaging.

The device uses a 32-channel digital beamformer with 96 or 128 array elements depending on probe model, supports B-mode, M-mode, Color Doppler, Power Doppler, and Pulsed Wave Doppler modes with various combined modes, operates via Wi-Fi with Bluetooth support for device discovery, and employs rechargeable Li-ion batteries. It conforms to IEC 62359:2017 for acoustic output measurement, whereas predicates cited UD 2-2004 and UD 3-2004 standards.

IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility), IEC 62133-2 (battery safety), IEC 62359 (acoustic output), IEC 62304 (software), IEC 60601-2-37 (ultrasound systems), ANSI IEEE USEMCSC C63.27 (wireless coexistence), FCC 15/18 (wireless certification), and ISO standards for biocompatibility, risk management, labeling, and quality systems.

The subject device shares identical indications for use with the primary predicate (NUSONO Handheld Ultrasound Scanner K242681) and uses the same fundamental ultrasound technology. Although it provides additional combined imaging modes (B+PW+Color Doppler, B+PDI, B+DPDI), these are constructed solely from individual modes already present in predicates and do not introduce new diagnostic functionality. The difference in acoustic output standards (IEC 62359:2017 vs. UD 2/UD 3) does not raise new safety or effectiveness concerns as both provide equivalent technical requirements. Non-clinical testing confirmed safety and performance substantially equivalent to predicates.