NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)

The NUSONO Handheld Ultrasound Scanner is a portable, software-controlled diagnostic ultrasound system that wirelessly connects to iOS or Android mobile devices via Wi-Fi. It acquires and displays real-time ultrasound images for diagnostic imaging and fluid flow analysis across multiple clinical applications including fetal, abdominal, cardiac, and musculoskeletal imaging, intended for use by trained healthcare professionals in clinical settings.

The device uses a 128-channel beamformer and image signal processing technology, employs Wi-Fi-based wireless transducers, and runs on rechargeable lithium-ion batteries. Three scanner models (convex, linear, and phased array) support B mode, M mode, Color Doppler, Power Doppler, and combined imaging modes. It displays images on standard commercial mobile devices running iOS 14–15 or Android 12+, unlike the predicate device which also supported Windows displays.

Compliance demonstrated to IEC 60601-1 (general medical device safety), IEC 60601-1-2 (electromagnetic immunity), IEC 60601-2-37 (ultrasonic equipment), IEC 62304 (software lifecycle), IEC 62366-1 (usability), ISO 10993 series (biocompatibility), ISO 14971 (risk management), ISO 13485 (quality management), and security standards including ANSI/AAMI SW96:2023, NIST Cybersecurity Framework, and IEC 81001-5-1.

The subject device shares identical indications for use, product codes (IYN, IYO, ITX), and fundamental ultrasound imaging technology with the primary predicate Leltek LU700 Series (K222365) and reference devices. Both systems use Wi-Fi wireless transducers, rechargeable batteries, mobile device displays, and provide the same imaging modes and clinical applications. The comparison table demonstrates substantial alignment in intended use, transducer types, operational modes, and applicable safety/performance standards, with only minor differences in display platform (iOS/Android versus Windows addition) that do not affect safety or efficacy.