DEPLOYDatabase

Company

SKIA

Korean medical device company developing SKIA HEAD, a tablet-based augmented reality (AR) surgical guidance system that projects 3D anatomical models onto a…

HQ
South Korea

Overview

Korean medical device company developing SKIA HEAD, a tablet-based augmented reality (AR) surgical guidance system that projects 3D anatomical models onto a patient's body during surgery. FDA 510(k) cleared (K251577) for AR-guided surgical navigation. Expanding to US market with Structure partnership.

Verified record

Verified deployments
None on file
Active incidents
None on file

Key facts

FDA 510(k)

K260723 cleared July 9, 2026 — AR surgical guidance system

Type

Traditional 510(k)

Product

SKIA HEAD — tablet-based AR surgical guidance system

FDA clearance

510(k) cleared (K251577) — AR-guided surgical navigation

Technology

Augmented reality projects 3D anatomical models onto patient body during surgery

US expansion

Partnership with Structure for US market entry

Data & sources

Government records

1

Web sources

1

2 sources backing this record.View all →

SKIA on the deployment map

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Safety record

No incidents on record for SKIA.

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Recent coverage

SKIA in third-party press