6450 Ultrasound System (MyLabE80); 6450 Ultrasound System (MyLabE85)

The 6450 Ultrasound System (MyLabE80 and MyLabE85 models) is a general-purpose diagnostic ultrasound scanner used to collect, display, and analyze ultrasound images during imaging procedures. It supports multiple clinical applications including cardiac, vascular, general imaging, and women's health across various anatomical districts and access routes (transvaginal, transesophageal, intraoperative, etc.). The system operates in B-Mode, M-Mode, Doppler, Color Flow Mapping, Elastosonography, 3D/4D, and other advanced imaging modes.

The 6450 employs the same fundamental technological characteristics as its predicate device (K192157). New features include XStrain LA software for Left Atrium strain analysis and a newly added IHX 6-25 probe equivalent to the previously cleared IH 6-18. Both models implement Microsoft Windows 10 operating system identical to the predicate. An Easy-To-Clean (ETC) keyboard variant is available for disinfection compatibility. Acoustic power levels remain below FDA limits, and materials have been evaluated for safety.

ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2:2014 + AMD1:2020, IEC 60601-1-6:2010+A1:2013, IEC 60601-2-37:2007 +A1:2015, NEMA UD 2-2004 (R2009) for acoustic output measurement, and NEMA UD 3-2004 (R2009) for thermal and mechanical output indices.

The device is substantially equivalent because it shares identical intended use, clinical applications, imaging modes, and fundamental technological platform with the predicate 6450 MyLabX8. New software features (XStrain LA) are extensions of previously cleared functionality. The new IHX 6-25 probe passed biocompatibility and image performance testing equivalent to the cleared IH 6-18. The device complies with all applicable electrical, physical, and safety standards identical to the predicate, with acoustic outputs below FDA limits.