ULTIMUS Series Ultrasound Diagnostic System

The ULTIMUS Series is a general-purpose ultrasound diagnostic system consisting of a mobile console with touch panel display and various electronic array transducers. It is intended for use by qualified physicians for imaging, measurement, and analysis of the human body and fluids in hospital or clinic settings, supporting clinical applications including abdominal, obstetric, cardiac, vascular, and pediatric imaging.

The ULTIMUS Series operates in multiple imaging modes (B, M, PW Doppler, CW Doppler, Color Doppler, 3D/4D, Harmonic Imaging) and includes various processing functions (Tissue Doppler, Elastography, Strain Imaging, Shear Wave Elastography). It has the same acoustic output specifications as the predicate (Track 3; Ispta.3 ≤ 720 mW/cm², MI ≤ 1.9, TI ≤ 6.0) and uses similar probe types (phased array, convex array, linear array, endocavity).

The device complies with IEC 60601-1:2005 (medical electrical equipment safety), IEC 60601-1-2 Edition 4.1 (electromagnetic disturbances), IEC 60601-2-37 Edition 2.1 (ultrasonic diagnostic equipment), IEC62359 (thermal and mechanical indices), ISO 10993 series (biocompatibility), IEC62304 (software lifecycle), and IEC62366-1 (usability engineering).

The ULTIMUS Series and predicate GE LOGIQ E10 share identical intended use, patient population, use environment, indications for use (except ULTIMUS excludes Transesophageal and Intraoperative which do not impact safety), equivalent biocompatible materials, and identical electrical and acoustic safety specifications. Both employ fundamental ultrasonic diagnostic technology with substantially similar imaging modes, functions, and measurement capabilities, and the minor differences in specific operating features do not introduce new safety or effectiveness issues.