LOGIQ Fortis

The LOGIQ Fortis is a full-featured diagnostic ultrasound system intended for use by qualified physicians to evaluate multiple anatomical areas including fetal/obstetrics, abdominal, cardiac, vascular, musculoskeletal, and other regions. It operates in multiple imaging modes (B, M, Doppler, Color, 3D/4D, Elastography, etc.) and is designed for use in hospitals or medical clinics.

The proposed LOGIQ Fortis employs the same fundamental ultrasound technology as its predicate device (K231989) with identical imaging modes and hardware, except for GPU replacement due to end-of-life, addition of new probes (12S-D, 9L-D), expanded software features (Auto Abdominal Color Assistant 2.0, Auto Aorta/CBD Measure Assistant, UGFF, Viewpoint, RFID Reader Login), and new keyboard keys for additional software functions.

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. Testing included acoustic output, biocompatibility, cleaning/disinfection, thermal, electrical, electromagnetic, and mechanical safety evaluation.

The proposed LOGIQ Fortis is substantially equivalent to predicate K231989 because both systems are intended for diagnostic ultrasound imaging with identical clinical indications, employ the same fundamental ultrasound technology, have the same imaging modes, similar measurement and reporting capabilities, and conformance to recognized safety standards. The differences (new probes, software enhancements, GPU replacement) do not alter the fundamental intended use or safety/effectiveness profile.