# K253486: SKIA-Head (Model: SKIA-ST00)

- Pathway: 510(k) (Traditional)
- Applicant: Skia, Inc.
- Decided: Feb 23, 2026 after 129 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K913770 (1991). 58 ancestors in all.
No later device cites it as a predicate yet.
0 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223125: XR90 (XR90-Sys), Mediview Xr, Inc. (2023) Summary page 6.
- K230249: Ikshana, Immersivetouch (2023) Summary page 6.

## Indications for use
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).

Source page: https://510kreport.com/device/K253486
Methodology: https://510kreport.com/methodology