ViewMate™ Multi Ultrasound System (VMM-ICE-01); ViewMate™ Multi Ultrasound System (VMM-ICE-02)

The ViewMate Multi Ultrasound System (VMM-ICE-01 and VMM-ICE-02) is a general-purpose diagnostic ultrasound system for use by qualified healthcare professionals in hospitals and medical clinics. It performs ultrasound imaging, measurement, display, and analysis of the human body and fluid in applications including abdominal, cardiac, pediatric, neonatal, musculoskeletal, and vascular examinations, supporting multiple imaging modes including B, M, Doppler, color flow, and tissue harmonic imaging.

The subject device has the same intended uses, patient contact materials, acoustic power levels, and electrical/physical safety design as the predicate device VMM-ICE-01 (K222754). New differences include software version 02 versus 01, two models (VMM-ICE-01 and VMM-ICE-02) versus one, addition of EnSite X integration function, V1/V2 velocity ratio measurement capability, and a new P9-3icSE transducer cleared under K251231.

NEMA UD 2-2004 (acoustic output), ANSI AAMI ES60601-1:2005 (electrical safety), IEC 60601-1-2 (electromagnetic disturbances), IEC 60601-1-6 (usability), IEC 60601-2-37 (ultrasonic equipment requirements), ISO 14971 (risk management), ISO 10993-1 (biocompatibility), IEC 62304 (software lifecycle), and IEC 62366-1 (usability engineering).

The subject device is substantially equivalent because it maintains identical indications for use, imaging modes, and safety design as the predicate; all new features (EnSite X, V1/V2, new transducer, software version) are enhancements or improvements to already-cleared functions that do not introduce new clinical risks or new intended uses; and the device passes the same non-clinical testing standards with acoustic power levels below FDA-recommended limits.