Intended Use

LOGIQ Focus is a general-purpose diagnostic ultrasound system intended for qualified and trained healthcare professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid across multiple regions and indications.

Technology

The system comprises a mobile console, control panel, display monitor, and multiple compatible transducers (convex, linear, sector, mechanical 4D, wireless). It offers several imaging modes such as B, M, Doppler, 3D/4D, elastography, and integrates AI-based workflow tools for automated anatomy identification and exam preset selection.

Performance

AI features were validated on datasets from multiple patients and probes with pre-specified accuracy, sensitivity, specificity, and segmentation criteria (all metrics exceeded 80%). Non-clinical tests included acoustic output, biocompatibility, cleaning/disinfection, electrical and mechanical safety, and DICOM conformance.

Predicate Devices

No predicate devices specified

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