Diagnostic Ultrasound System (MX6); Diagnostic Ultrasound System (MX6S); Diagnostic Ultrasound System (MX6T); Diagnostic Ultrasound System (MX6 Exp); Diagnostic Ultrasound System (MX6 Pro); Diagnostic Ultrasound System (MX6 Super); Diagnostic Ultrasound System (MXG); Diagnostic Ultrasound System (Emerus MX6); Diagnostic Ultrasound System (Emerus MX6 Exp); Diagnostic Ultrasound System (Anesus MX6); Diagnostic Ultrasound System (Anesus MX6 Exp); Diagnostic Ultrasound System (Crius MX6);

The MX6/MX5/MX3 series Diagnostic Ultrasound System is a general-purpose, mobile, software-controlled ultrasonic diagnostic system for imaging adults, pregnant women, pediatric patients, and neonates. It acquires and displays ultrasound images in multiple modes (B, M, PWD, CWD, Color Doppler, Tissue Harmonic Imaging, 3D/4D, Strain Elastography, and Contrast imaging) for use in ophthalmic, fetal, abdominal, cardiac, musculoskeletal, and other clinical applications in hospitals or medical clinics.

The subject device transmits ultrasonic energy into patients, performs post-processing of received echoes to generate onscreen anatomic displays, and enables specialized measurements and calculations. Its acoustic power levels are below FDA-specified limits per the 'Marketing Clearance of Diagnostic Ultrasound Systems and Transducers' guidance, matching predicate devices Consona N9 and MX7. Patient contact materials are either identical to predicates or tested under ISO 10993-1. The device is designed to comply with FDA-recognized electrical and physical safety standards and incorporates equivalent features and functions as Consona N9.

NEMA UD 2-2004 (acoustic output); ANSI AAMI ES60601-1:2005 and amendments (electrical safety); IEC 60601-1-2 Edition 4.1 (electromagnetic immunity); IEC 60601-1-6 Edition 3.2 (usability); IEC 60601-2-37 Edition 2.1 (ultrasound-specific safety); ISO 14971 (risk management); ISO 10993-1 (biocompatibility); IEC 62304 (software lifecycle); IEC 62366-1 (usability engineering).

The subject device is substantially equivalent because it shares the same intended uses as Consona N9 (main predicate) with the addition of ophthalmic applications already cleared in predicate MX7. All systems employ identical technological approaches: ultrasonic transmission, echo post-processing, anatomic display generation, and specialized measurements. Acoustic power, material biocompatibility, electrical safety design, and operational modes are equivalent or superior to predicates. Non-clinical testing under recognized safety and performance standards demonstrates the device meets the same safety profile as the predicates without requiring new clinical evidence.