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 ultrasound imaging procedures. It supports multiple clinical applications including cardiac, vascular, general imaging, and women's health across various patient populations and anatomical access routes. The system operates in multiple modes including B-Mode, M-Mode, Doppler, Color Flow Mapping, Elastosonography, and 3D/4D imaging.

The 6450 Ultrasound System employs the same fundamental technological characteristics as its predicate device (K241671), including identical imaging modes, operating capabilities, measurement functions, probe compatibility, and Microsoft Windows 10 operating system. New features include UroFusion (an AI-algorithm for prostate contouring that improves the previously cleared Virtual Navigator feature), plus three additional features from K243253: AutoCM, AutoOB, and XStrain RV. All systems are designed for the same clinical uses with equivalent acoustic power levels below FDA limits.

The device was tested and found compliant with ANSI/AAMI ES60601-1:2005/AMD2:2021, ANSI/AAMI/IEC 60601-1-2:2014 + AMD1:2021, IEC 60601-1-6:2010+A1:2013 + A2:2020, IEC 60601-2-37:2007 + A1:2015, NEMA UD 2-2004 (R2009), and NEMA UD 3-2004 (R2009). AI algorithm performance was validated using DICE Volume ≥0.7 and computational time <15 seconds criteria across multiple subgroups (age, prostate volume, PI-RADS score, BMI) and MRI manufacturer platforms.

The 6450 Ultrasound System is substantially equivalent to predicate K241671 because it maintains identical intended use, clinical applications, imaging modes, measurement capabilities, probe compatibility, and design compliance with approved electrical and physical safety standards as the predicate. The new UroFusion feature represents an improvement of the previously cleared Virtual Navigator feature (already on the predicate), and three additional features previously cleared under K243253 are being added. Non-clinical testing confirms conformance with applicable medical device safety standards, and no clinical studies were required to support substantial equivalence.