LOGIQ Totus

The LOGIQ Totus is a full-featured diagnostic ultrasound system consisting of a mobile console with digital acquisition, processing, and display capability. It is intended for use by qualified physicians for ultrasound evaluation across multiple clinical applications including fetal/obstetrics, abdominal, cardiac, peripheral vascular, musculoskeletal, and transesophageal imaging, operating in multiple modes (B, M, Doppler, Color Doppler, Harmonic Imaging, Elastography, and combined modes).

The proposed device employs the same fundamental scientific technology as its predicate. Key differences include addition of four new probes (C2-9-D, L4-20t-D, L3-9i-D, 6Tc-RS migrated from LOGIQ E10s), new software features including Auto Renal Measure Assistant and Ultrasound Guided Fat Fraction, GPU replacement (NVIDIA T1000 to T1000E), and various interface and workflow improvements. Acoustic power levels remain below FDA limits.

The device complies with ANSI AAMI ES60601-1, IEC 60601-1 Edition 3.2, IEC 60601-2-37 Edition 3.0, IEC 60601-1-2 Edition 4.1, IEC 62359 Edition 2.1, ISO 10993-1, ISO 14971, NEMA PS 3.1-3.20, and AAMI TIR69:2017. Testing included acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety evaluations.

The proposed LOGIQ Totus is substantially equivalent to the predicate LOGIQ Totus (K232381) based on identical intended use for diagnostic ultrasound imaging, same imaging modes and fundamental technology, similar measurement and image capture capabilities, and compliance with recognized safety standards. Clinical studies demonstrated the new UGFF feature maintains strong correlation with MRI-PDFF across multiple populations, and migrated software features were previously cleared on other predicate devices.