{"id":"67bf7c44-3d5e-4602-86be-91b1b3290281","companyId":"f59251fd-0a27-4d58-842c-0ae8b46d49c6","modelName":"SKIA HEAD","slug":"skia-head","description":"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.","formFactor":"surgical","industryVertical":null,"environment":null,"maturityStage":"commercial","lifecycleState":"active","supersededByModelId":null,"specs":{},"manufacturerSerial":null,"reviewStatus":"reviewed","sources":[{"url":"https://www.prnewswire.com/news-releases/skia-head-ar-surgical-guidance-receives-fda-510k-clearance-eyes-us-expansion-with-structure-partnership-302785511.html","label":"SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance","title":"SKIA HEAD: AR Surgical Guidance Receives FDA 510(k) Clearance","mediaType":"article","sourceName":"PR Newswire"},{"url":"https://www.skia.kr/","title":"SKIA","sourceName":"SKIA"},{"url":"https://www.skia.kr/about-us","title":"About SKIA","sourceName":"SKIA"},{"url":"https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K253486","title":"510(k) Premarket Notification K253486","sourceName":"U.S. Food and Drug Administration"}],"aliases":[],"collisionRisk":"low","reviewNote":null,"manufacturerTermForTeleop":null,"keyFacts":[{"label":"FDA 510(k) clearance (regulator, May 2026)","value":"Cleared under K253486 as SKIA-HEAD, model SKIA-ST00, an image-processing system; SKIA announced it on May 29 2026."},{"label":"System (company-stated)","value":"A tablet-based AR surgical guidance system projecting 3D anatomy from preoperative imaging onto the patient in real time."},{"label":"Imaging (company-stated)","value":"Converts CT and MR data into 3D meshes, with segmentation tools for planning."},{"label":"Alignment (company-stated)","value":"AI recognition detects the patient and aligns the 3D model during surgery; Structure Sensors map the environment and anatomy."},{"label":"US entry plan (company-stated)","value":"Plans US entry through a formal partnership with Structure, pairing its sensors with SKIA software. A plan, not install counts."},{"label":"Target market (company-stated)","value":"Pitched as an alternative to bulky stationary navigation hardware, for smaller hospitals and outpatient centers."},{"label":"CEO","value":"Jong-Myoung Lee."}],"createdAt":"2026-08-24T05:03:51.541Z","updatedAt":"2026-10-10T03:48:28.832Z","unitsInFieldClaimed":null,"unitsInFieldVerified":null,"unitsManufacturedClaimed":null,"unitsManufacturedVerified":null,"unitsAsOf":null,"unitsSource":null,"salesModel":null,"priceUndisclosedSince":null,"autonomyClass":null,"autonomyStatement":null,"autonomyStatementSource":null,"demoForensics":null,"exportControlClass":null,"minCommitment":null,"warrantyTerms":null,"serviceModel":null,"productionRateClaimed":null,"productionRateEvidenced":null,"teleopRatioDisclosed":null,"interventionRateDisclosed":null,"jsonLd":{"@context":"https://schema.org","@type":"Product","@id":"https://registry.deploy.report/models/skia-head","url":"https://registry.deploy.report/models/skia-head","name":"SKIA HEAD","description":"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.","identifier":"67bf7c44-3d5e-4602-86be-91b1b3290281","category":"surgical","publisher":{"@id":"https://deploy.report/#organization"}},"framework_metadata":{"framework_schema_version":"0.1.0","verification_status":"verified","maturity_stage":"commercial","lifecycle_state":"active","architectural_position":{"cohort":"surgical","sub_cohorts":[]},"within_cohort_verified_vs_claimed_pair":null,"cap_flags":[],"verification_depth":{"sources_count":4,"primary_source_types":["primary-fda-database"]}}}