LOGIQ Vita; LOGIQ Vita Pro; LOGIQ Vita Express; LOGIQ Vita Plus; LOGIQ Vita Power; LOGIQ S20; LOGIQ S20 Pro; LOGIQ S20 Express; LOGIQ S20 Plus; LOGIQ S20 Power

The LOGIQ Vita/S20 Series are full-featured diagnostic ultrasound systems designed for qualified physicians to perform ultrasound evaluation across multiple clinical applications including fetal/obstetric, abdominal, cardiac, vascular, musculoskeletal, and intraoperative imaging. The mobile console supports multiple imaging modes (B, M, Doppler, Color, Power Doppler, 3D/4D, Elastography, and combinations) and is intended for use in hospitals or medical clinics.

The proposed device uses a 14-inch touch panel (versus 12.1-inch on predicate), a 23.8-inch monitor (HDU for Vita series, LCD for S20 series versus LED LCD on predicate), and is based on the LOGIQ Fortis trolley console base with the LOGIQ Totus operator panel. Software features are identical except the proposed device does not support Koios Lite, Koios DS Connectivity, or Digital Expert. The device reuses 26 previously cleared probes without modification and maintains the same acoustic power levels below FDA limits.

The device complies with IEC 60601-1:2005, IEC 60601-2-37 Edition 3.0 2024, IEC 60601-1-2 Edition 4.1 2020, IEC 62359 Edition 2.1 2017, ISO 10993-1 Fifth edition 2018, ISO 14971 Third Edition 2019, NEMA PS 3.1–3.20 2024e (DICOM), and AAMI TIR69:2017 for RF wireless coexistence. Testing included acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety.

The proposed LOGIQ Vita/S20 Series are substantially equivalent to the predicate LOGIQ Fortis (K253366) because they share identical clinical indications, the same fundamental ultrasound technology, identical imaging modes, equivalent measurement and reporting capabilities, the same frontend and backend processing hardware, and compatible probe sets. The primary differences are cosmetic (touch panel size, monitor type, industrial design refresh) and removal of non-essential accessories/features, which do not affect safety or effectiveness for the intended diagnostic ultrasound applications.