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The SKIA-Head (SKIA-ST00) is a medical display system intended for 3D image visualization and image interaction in conjunction with traditional imaging and monitors. The virtual images are generated from 3D volumetric data previously acquired from CT sources and visualized to 3D patient images being displayed on a tablet PC using 3D cameras.

The device is intended to provide visual information and reference to be used by health care professionals for analysis of surgical options during pre-operative planning.

The device may also be used in a limited, early intraoperative context, specifically during phases in which the patient's skin surface remains consistent with the CT-acquired skin surface model. This generally corresponds to the period after anesthesia but before any manipulation that would deform or alter the patient's external skin surface. This represents a pre-operative to early intraoperative transition phase, during which the patient's posture is fixed and the skin surface remains sufficiently stable for skin-based registration.

The system is intended for visualization and reference purposes only and is not intended for real-time surgical navigation, instrument tracking, or stereotactic guidance.

This device is intended for prescription use only (Rx Only).

The SKIA-Head is an augmented reality-based standalone software device. The device reconstructs digital anatomical 3D models based on pre-procedural computed tomography (CT) images for users to review and fuses it with a real-time patient video image displayed on a tablet PC to generate augmented reality. The system is comprised of SKIA_Processor, SKIA_Application, and SKIA-Server. Users need compatible off-the-shelf hardware such as hospital server to operate SKIA-Server, user's PC to operate SKIA_Processor, 3D camera device to scan a patient and shoot a real time patient video, and iPad to proceed registration and display the AR output image.

The SKIA-Head provides users with review functions such as image position movement, zoom in/out, image reset, image rotation, and segmentation of the CT images. The AR anatomical model fused with the real time patient video can help users accurately recognize the actual location and size of lesions in the patient.

The SKIA-Head projects virtual representations of a) a spatially scanned patient image map using a 3D camera and b) reconstructed CT-based 3D anatomical model. Accordingly, the use of SKIA-Head involves the co-registration of these two virtual objects and real time patient video image displayed on a tablet PC for visual information using projection to real patients.

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