ViewMateTM Ultrasound System

The ViewMate Ultrasound System is a general-purpose diagnostic ultrasound device for qualified healthcare professionals to perform imaging, measurement, display, and analysis of the human body and fluids in hospital or clinical settings. It supports a broad range of clinical applications including fetal, abdominal, cardiac, vascular, musculoskeletal, and other specialty ultrasound evaluations across multiple imaging modes.

The device operates in B-mode, M-mode, PWD, CWD, Color Doppler, combined modes, Color M-mode, 3D/4D, and CEUS imaging. Key technical features include harmonic imaging, directional and power Doppler, tissue elasticity assessment, ARFI, and shear wave imaging. Patient contact materials and acoustic power levels are identical to the predicate device ZS3, z.one pro, and the system is designed to comply with the same FDA-recognized electrical and physical safety standards.

NEMA UD 2-2004, ANSI AAMI ES60601-1:2005, IEC 60601-1-2 Edition 4.1, IEC TS 60601-4-2, IEC 60601-1-6 Edition 3.2, IEC 60601-2-37 Edition 2.1, ISO 14971, ISO 10993-1, IEC 62304, and IEC 62366-1.

The ViewMate has identical intended uses, imaging modes, patient contact materials, and acoustic power levels as the predicate device ZS3, z.one pro. New features (EnSite X integration and the P9-3icSE transducer) are enhancements of existing cleared functions that introduce no new intended uses and passed all relevant testing without clinical risk. All systems transmit ultrasonic energy, post-process received echoes, and allow specialized measurements—the same fundamental technology approach as the predicate.