Vscan Air

Vscan Air is a battery-operated, software-based portable ultrasound imaging system installed on Android or iOS devices with two wireless probes. It enables qualified healthcare professionals to visualize and measure anatomical structures and fluid including blood flow, supporting B-mode, color flow Doppler, pulsed wave Doppler, M-mode, and harmonic imaging across curved, linear, and sector array transducers for clinical applications including abdominal, cardiac, vascular, musculoskeletal, and interventional guidance.

The proposed Vscan Air employs the same fundamental scientific technology as its predicate device and maintains identical indications for use, imaging modes, transducers/hardware, and accessories. New additions include Auto bladder volume (using deep learning for automated caliper placement) and Caption AI compatibility (real-time cardiac guidance and ejection fraction estimation), plus service tools and quality improvements.

AAMI/ANSI ES60601-1:2005/(R)2012; IEC 60601-1-2 (Edition 4.1, 2020); IEC 60601-2-37 (Edition 2.1, 2015); IEC 62359:2017; ISO 14971:2019; ISO 10993-1:2018; IEC 60601-1-11 (Edition 2.1, 2020); IEC 60601-1-12 (Edition 1.1, 2020). Testing included acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety.

Substantial equivalence is based on identical intended use, indications, imaging modes, hardware, and transducers compared to the predicate Vscan Air (K231301). The new software features (Auto bladder volume and Caption AI) represent incremental additions building on previously cleared technologies in reference devices (Vscan Extend for bladder volume measurement, and separately cleared Caption Guidance and Caption Interpretation AutoEF), and all changes maintain compliance with applicable safety and performance standards without altering the fundamental diagnostic function or safety profile.