ES-Series

The ES-Series is an ultraportable ultrasound imaging system consisting of a software app running on a consumer computer and an external ultrasound probe connected via USB-C. It performs general-purpose pulse-echo ultrasound imaging and quantitative imaging studies including shear wave elastography, tissue brightness measurements, and speed of sound estimation, primarily for abdominal imaging and liver/spleen assessment in both adult and pediatric patients with liver disease.

ES-Series has identical operating modalities and features to its predicate (B-mode, 2D-Transient Elastography, Shear Wave Speed estimation, attenuation coefficient, backscattering coefficient, and Speed of Sound). Three technological improvements include refined signal processing for spleen stiffness measurement targeting higher stiffness values, addition of macOS operating system support alongside Windows, and implementation of EHR connectivity using HL7 FHIR standard.

IEC 60601-2-37 for electrical safety testing. FDA's Guidance for Industry on Content of Premarket Submissions for Device Software Functions was followed, with software classified at Basic Documentation Level. Bench testing was conducted on calibrated phantoms.

ES-Series is substantially equivalent to its predicate device (Hepatoscope, K232336) because they share identical intended use and indications for use. The three technological differences (spleen stiffness refinement, macOS support, EHR connectivity) do not raise new safety or effectiveness questions, as demonstrated by non-clinical performance testing including electrical safety, bench testing on phantoms, and software verification/validation. Clinical testing was not necessary.