6600 Ultrasound System (MyLabA50); 6600 Ultrasound System (MyLabA70)

The 6600 Ultrasound System (MyLabA50 and MyLabA70 models) is a diagnostic ultrasound scanner used to collect, display, and analyze ultrasound images during imaging procedures with supported probes. It supports cardiac, vascular, general imaging, and women's health applications across multiple anatomical districts and invasive access methods, operating in B-Mode, M-Mode, Doppler, Color Flow Mapping, Elastosonography, 3D/4D imaging, and other modes.

The 6600 Ultrasound System employs the same fundamental technological characteristics as the predicate device (6440 MyLabX90), including identical imaging modes, Windows 10 operating system, and measurement/digital image capabilities. New features include AutoOB (AI-powered obstetric biometric measurement), AutoCM (AI-powered cardiac measurement), XStrain RV analysis, new probe models (C 1-8E, L 3-15E, P 1-5E for A50; C 1-8A, P 1-5A for A70), and an optional Easy-to-Clean control panel configuration.

ANSI/AAMI ES60601-1:2005(R)2012 and A1:2012, C1:2009(R)2012, A2:2010(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); NEMA UD 3-2004 (R2009).

The proposed device is substantially equivalent because it shares the same fundamental technological platform, intended clinical use, and imaging capabilities as the predicate device. Acoustic output, biocompatibility, safety, and electrical/mechanical properties conform to the same medical device standards. The new AI-powered features (AutoOB, AutoCM) and new probe models are improvements of existing functionalities already available on the predicate device and do not create new risks or alter the fundamental diagnostic ultrasound imaging function.