NUSONO Handheld Ultrasound Scanner (NUSONO-C35); NUSONO Handheld Ultrasound Scanner (NUSONO-L75); NUSONO Handheld Ultrasound Scanner (NUSONO-P25)
Nurodata Inc.The NUSONO Handheld Ultrasound Scanner is a portable, software-driven ultrasound imaging system that interfaces wirelessly with mobile devices to provide high-resolution diagnostic imaging in various clinical applications. It supports multiple imaging modes, including B-mode, M-mode, Color Doppler, and Power Doppler, enabling healthcare professionals to effectively diagnose conditions across fetal, abdominal, pediatric, urology, gynecology, cardiac, and lung areas. By integrating with smartphones and tablets, it offers flexible, real-time imaging solutions for use in clinics, hospitals, and point-of-care settings, enhancing diagnostic confidence and accessibility.
Intended Use
Diagnostic ultrasound imaging and fluid flow analysis of the human body in multiple clinical applications such as fetal, abdominal, pediatric, urology, gynecology, cardiac, lung, small organs and musculoskeletal imaging; supports B mode, M mode, color and power Doppler imaging modes; intended for use by trained healthcare professionals in varied clinical environments.
Technology
The device is a wireless, handheld ultrasound diagnostic system that communicates via Wi-Fi with iOS or Android mobile devices. It includes multiple transducer types (convex, linear, phased array) depending on the model, and employs a 128-channel beamformer and image signal processing technology to acquire and display real-time, high resolution ultrasound images through a mobile app interface. It supports multiple ultrasound imaging modalities inclusive of B mode, Doppler modes, and combined imaging modes for enhanced diagnostic utility.
Performance
Non-clinical performance testing included measurement accuracy, system sensitivity, thermal, mechanical and electrical safety, biocompatibility, cleaning and disinfection, software and acoustic output compliance with multiple IEC, ISO and FDA standards ensuring safety and effectiveness. Clinical performance testing was not required as equivalence to predicate devices was established.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/6/2024
5 months - 2
FDA Approval
2/20/2025
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