{"id":"f59251fd-0a27-4d58-842c-0ae8b46d49c6","name":"SKIA","slug":"skia","description":"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).","status":"private","founded":2018,"hq":"Seoul, South Korea","hqLat":36.638392,"hqLng":127.6961188,"hqGeocodedAt":"2026-08-05T14:46:54.293Z","hqAddress":null,"hqPrecision":null,"website":"skia.org","fundingTotal":null,"type":"hardware","roles":[],"reviewStatus":"reviewed","heatIndex":52,"lifecycleState":"active","supersededByCompanyId":null,"sources":[{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260723","title":"FDA 510(k) K260723 SKIA","sourceName":"FDA","dateAccessed":"2026-07-23"},{"url":"https://www.aol.com/articles/skia-head-ar-surgical-guidance-130000000.html","title":"SKIA AR Surgical Guidance Receives FDA 510(k) Clearance","sourceName":"AOL/PR","dateAccessed":"2026-07-23"}],"keyFacts":[{"label":"FDA 510(k)","value":"K260723 cleared July 9, 2026 — AR surgical guidance system"},{"label":"Type","value":"Traditional 510(k)"},{"label":"Product","value":"SKIA HEAD — tablet-based AR surgical guidance system"},{"label":"FDA clearance","value":"510(k) cleared (K251577) — AR-guided surgical navigation"},{"label":"Technology","value":"Augmented reality projects 3D anatomical models onto patient body during surgery"},{"label":"US expansion","value":"Partnership with Structure for US market entry"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"atsProvider":null,"atsSlug":null,"factoryLocations":null,"manufacturingCapacity":null,"orgType":null,"burnSignal":null,"litigationEvents":null,"insurancePostureDisclosed":null,"unitEconomicsDisclosed":null,"tickerSymbol":null,"stockExchange":null,"secCik":null,"revenueUsd":null,"revenueBasis":null,"revenueAsOf":null,"employeeCount":null,"employeeCountBasis":null,"employeeCountAsOf":null,"marketCapUsd":null,"marketCapAsOf":null,"marketCapSource":null,"createdAt":"2026-07-24T15:21:50.877Z","updatedAt":"2026-08-24T05:03:18.751Z","jsonLd":{"@context":"https://schema.org","@type":"Organization","@id":"https://registry.deploy.report/companies/skia","url":"https://registry.deploy.report/companies/skia","name":"SKIA","description":"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).","identifier":"f59251fd-0a27-4d58-842c-0ae8b46d49c6","foundingDate":"2018","address":"Seoul, South Korea","publisher":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":null,"lifecycle_state":null,"architectural_position":{"cohort":null,"sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":2,"primary_source_types":["primary-fda-database"]}}}