Diagnostic Ultrasound System (Nano C5, Nano C5 EXP, Nano L12, and Nano L12 EXP)

The Nano Series Diagnostic Ultrasound System is a portable ultrasound imaging device consisting of an app installable on iOS or Android devices paired with convex and linear transducers using wired or wireless communication. It is intended for use by trained healthcare professionals in hospitals, clinics, ambulances, or homes for diagnostic ultrasound evaluation across multiple clinical applications including abdominal, gynecologic, obstetric, cardiac, musculoskeletal, and vascular imaging.

The Nano Series offers B mode, M mode, Doppler modes, and Harmonic Imaging with combination modes, supporting dual imaging, speckle reduction imaging (eSRI), auto trace, zoom, ECG wave, eVocal, eWorks, and remote diagnosis features. The system is comparable to the predicate Lumify device but with a narrower set of explicitly listed clinical applications, though the imaging modes and measurement capabilities (distance, circumference, area, angle, velocity, heart rate) are substantially identical.

Testing per IEC 60601-1:2005+A1:2012+A2:2020 (general medical electrical equipment safety), IEC 60601-1-2:2014+A1:2020 (electromagnetic compatibility), IEC 60601-2-37:2007+A1:2015 (ultrasonic diagnostic equipment), IEC 60601-1-11:2015+A1:2020 (home healthcare environment), and IEC 60601-1-12:2014+A1:2020 (emergency medical services). FDA guidance documents on marketing clearance of diagnostic ultrasound systems and device software functions were also applied.

The Nano Series is substantially equivalent to the Philips Lumify predicate device because both employ identical ultrasound imaging technology, support the same core imaging modes (B, Doppler, M, Harmonic), use iOS/Android platforms, offer identical measurement functions, include rechargeable batteries, and are portable diagnostic systems. Bench testing and software verification/validation demonstrated the subject device meets relevant consensus standards and is as safe and effective as the predicate, with no technological differences that raise different safety or effectiveness questions.