DEPLOYDatabase

Robot model

SKIA HEAD

surgicalcommercialby SKIA

Tablet-based augmented reality surgical guidance system that converts preoperative CT/MRI imaging into 3D anatomical reconstructions projected onto the…

Manufacturer
SKIA
Form factor
surgical
Maturity
commercial
Lifecycle
active

The verified answer

As of Oct 2026, DEPLOY verifies SKIA HEAD, a surgical by SKIA (commercial). 4 sources back the record.

Overview

Tablet-based augmented reality surgical guidance system that converts preoperative CT/MRI imaging into 3D anatomical reconstructions projected onto the patient's body in real time. Powered by medical-grade Structure Sensors for spatial mapping and AR overlay alignment. FDA 510(k) cleared (K251577) in May 2026 for AR-guided surgical navigation.

Verified vs. claimed

Maturity stage
commercial(Commercially deployed with revenue-generating operations.)
Sources on file
View all sources →

No verified deployments on file. DEPLOY tracks independently-sourced deployment evidence separately from manufacturer capability claims.

Key facts

FDA 510(k) clearance (regulator, May 2026)

Cleared under K253486 as SKIA-HEAD, model SKIA-ST00, an image-processing system; SKIA announced it on May 29 2026.

System (company-stated)

A tablet-based AR surgical guidance system projecting 3D anatomy from preoperative imaging onto the patient in real time.

Imaging (company-stated)

Converts CT and MR data into 3D meshes, with segmentation tools for planning.

Alignment (company-stated)

AI recognition detects the patient and aligns the 3D model during surgery; Structure Sensors map the environment and anatomy.

US entry plan (company-stated)

Plans US entry through a formal partnership with Structure, pairing its sensors with SKIA software. A plan, not install counts.

Target market (company-stated)

Pitched as an alternative to bulky stationary navigation hardware, for smaller hospitals and outpatient centers.

Data & sources

Government records

1

Web sources

3

4 sources backing this record.View all →

Pricing

No verified price is on record for SKIA HEAD. Physical-AI systems are often sold through enterprise contracts or operated as a service rather than at a public list price.

Recent activity

Every change to this record is dated, sourced, and independently verified where marked.

Full change history →

Safety record

No incidents on record for SKIA HEAD.

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

Sources (4)

  1. SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance · https://www.prnewswire.com/news-releases/skia-head-ar-surgical-guidance-receives-fda-510k-clearance-eyes-us-expansion-with-structure-partnership-302785511.html
  2. https://www.skia.kr/
  3. https://www.skia.kr/about-us
  4. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253486

Mentioned on (2)

Registry pages whose text names SKIA HEAD.

Companies (1)

SKIA

Robots and products (1)

SKIA Body

Common questions

What is SKIA HEAD?
Tablet-based augmented reality surgical guidance system that converts preoperative CT/MRI imaging into 3D anatomical reconstructions projected onto the patient's body in real time. Powered by medical-grade Structure Sensors for spatial mapping and AR overlay alignment. FDA 510(k) cleared (K251577) in May 2026 for AR-guided surgical navigation.
How much does SKIA HEAD cost?
SKIA HEAD's price is not publicly disclosed. DEPLOY has no verified price on record for SKIA HEAD from SKIA. Physical-AI systems like this are often sold through enterprise contracts or operated as a service rather than at a public list price; check the manufacturer for the latest.
Is SKIA HEAD actually deployed in the real world?
SKIA HEAD is recorded at the commercial stage, but DEPLOY has no deployment verified at a named site yet; vendor deployment claims are not independently confirmed here. Manufacturer capability claims should be read as claims pending independent verification.
Who makes SKIA HEAD?
SKIA HEAD is made by SKIA, based in Seoul, South Korea, founded in 2018.
Can you buy SKIA HEAD?
SKIA HEAD is in commercial deployment and is sold to operators; contact the manufacturer to buy, and see the pricing section for any recorded price.
What are alternatives to SKIA HEAD?
On the DEPLOY registry, comparable surgical robots to SKIA HEAD include da Vinci (and Ion), Edge Multi-Port Surgical Robot, Edison Histotripsy System, Stryker Mako SmartRobotics.
How does SKIA HEAD compare to da Vinci (and Ion)?
SKIA HEAD and da Vinci (and Ion) (Intuitive Surgical · 15 deployments) are both surgical robots on the DEPLOY registry. SKIA HEAD has 0 verified deployments on record. Compare both records for specs, safety, deployments, and verified-vs-claimed autonomy.
Is SKIA HEAD a top surgical?
On DEPLOY's intelligence score, which blends verified deployments, safety, adoption, media, and IP signals, SKIA HEAD ranks in roughly the top 80% of surgical models tracked by the registry.
What is SKIA HEAD's maturity stage?
SKIA HEAD is at the commercial stage on the DEPLOY maturity ladder (research, prototype, pilot, commercial, production). Commercial stage means production-grade deployments are operating at named customer sites.
Where is SKIA HEAD deployed?
No verified deployments of SKIA HEAD are currently on the DEPLOY registry. DEPLOY records deployments only when verified at a named site with a primary source; absence may reflect pre-deployment, research, or manufacturer-internal use.
Is SKIA HEAD safe?
SKIA HEAD has no incidents on record in the DEPLOY registry. This does not constitute a safety guarantee; it reflects the incidents DEPLOY has tracked and verified to date.
Methodology: Verified · 4 sources (1 primary) · last reviewed 2026-10-10

Verification posture

Verified

High confidence

Review state

Stable

Last reviewed 2026-10-10

Maturity + lifecycle

Maturity stage: commercial

Lifecycle: active

Architectural position

Cohort: surgical

Sources by quality tier

3
unclassified
Unclassified source
1
primary-fda-database
FDA database

The framework is documented at /methodology. Corrections at /corrections. Reviewer: DEPLOY editorial team.

Methodology surface for SKIA HEAD.