Accuro XV

The Accuro XV is a portable ultrasound imaging system for use by qualified healthcare professionals in hospital or clinic settings. It features a conformable three-dimensional ultrasound probe with motorized scanning that automates large field-of-view image acquisitions for musculoskeletal conventional and superficial imaging applications.

The key difference is the Accuro XV volumetric imaging probe, which contains a 384-element linear array at 6.5 MHz center frequency with 360-micron pitch. Volumetric scans are automatically acquired via motorized linear translation over 10 cm, and a compliant polyurethane stand-off medium provides a conformable patient contact surface. The predicate (Accuro 3S) uses a Dual-Array convex probe, while the reference device (Logiq E9) uses mechanically similar three-dimensional probes with differences in geometry, patient contact material, and conformability.

IEC 60601-1 Edition 3.2, IEC 60601-1-2 Edition 4.1, IEC 60601-1-6 Edition 3.2, IEC 60601-2-37 Edition 2.1, IEC 62304, IEC 62366-1, IEC 62359, ISO 10993-1, ISO 14971, NEMA UD 2-2004, NEMA PS 3.1-3.20e (DICOM), and AAMI TIR69:2017.

Accuro XV is substantially equivalent to the predicate Accuro 3S and reference device Logiq E9 because it shares the same intended use, intended user, patient population, and clinical applications. Non-clinical testing demonstrates acoustic output, safety, cleaning/disinfection, electrical, thermal, mechanical, and EMC compliance with applicable standards. The probe geometry and material differences do not raise new safety or effectiveness issues, supported by risk management and performance validation testing.