SKIA-Head (Model: SKIA-ST00)

The SKIA-Head is a medical display system that reconstructs 3D anatomical models from CT images and fuses them with real-time patient video captured by a 3D camera on an iPad to generate augmented reality visualizations. It is intended for healthcare professionals to use during pre-operative surgical planning and in a limited early intraoperative phase for visual reference only, not for real-time navigation or instrument tracking.

The device uses markerless, computer vision-based registration (similar to the secondary predicate Ikshana) rather than marker-based sensor fusion like the primary predicate XR90. It displays AR output on an iPad rather than a head-mounted display, and processes CT DICOM data with automatic registration and semi-transparent 3D visualization of patient skin models and segmented anatomy.

IEC 60601-1:2005+A1:2012 (electrical safety), IEC 62366-1:2015+A1:2020 (usability), IEC 62304:2007 (software lifecycle), EN ISO 14971:2019 (risk management), NEMPA PS 3.1–3.20 2024e (DICOM standard), and IEC 62563-1:2021 (display performance).

SKIA-Head has the same intended use and principles of operation as the predicate devices for CT-based 3D visualization and image interaction. Differences such as tablet display versus head-mounted display and markerless versus marker-based registration are matters of form, not function. The core technology for visualizing and interacting with CT-based 3D images remains functionally equivalent, and differences in scope (e.g., XR90's ultrasound guidance) do not introduce new safety or effectiveness questions.