DEPLOYDatabase

Company

SKIA

South Korean medtech company developing tablet-based augmented reality (AR) surgical guidance systems.

Founded
2018
HQ
Seoul, South Korea
Status
private

The verified answer

As of Aug 2026, DEPLOY verifies SKIA: 2 models. 2 sources back the record.

CategorySurgical robots

Overview

South Korean medtech company developing tablet-based augmented reality (AR) surgical guidance systems. Its flagship SKIA HEAD platform converts preoperative CT/MRI imaging into 3D anatomical reconstructions projected onto the patient's body in real time, powered by medical-grade Structure Sensors. The company received FDA 510(k) clearance in May 2026 and is expanding to the US market through a hardware partnership with Structure.

SKIA's broader portfolio includes SKIA Body (used in 80+ hernia surgeries in India), SKIA Face, and SKIA Breast (in confirmatory clinical trials at Seoul National University, Yonsei Severance, and Ewha Womans University Hospital).

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 →

Partnerships

Every company SKIA has built with, alongside the ones only announced in a press release.

2 total1 just announced

Most-frequent partners

  1. 1AWS1× joint976 total
  2. 2Structure1× joint

Most recent

  1. with Structurejust announced

SKIA on the deployment map

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Relationships

Current leadership (1)

Safety record

No incidents on record for SKIA.

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Full safety record: incidents, sourcing, and exposure data →

Recent coverage

SKIA in third-party press