SKIA-Head (Model: SKIA-ST00)— 510(k) K253486

Name: FDA 510(k) clearance K253486
Creator: U.S. Food and Drug Administration
Published: 2026-02-23

Substantially Equivalent

Skia, Inc.

FDA 510(k) clearance K253486 for SKIA-Head (Model: SKIA-ST00), Substantially Equivalent on 2026-02-23. Applicant: Skia, Inc.. Device class: 2.

Summary

Skia's SKIA-Head is listed with model SKIA-ST00 under product code LLZ (System, Image Processing, Radiological). The record doesn't describe it beyond the name and that code name.

Class II, 21 CFR 892.2050. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k). The record flags it as a third-party review.

Skia filed from Seoul, South Korea. The decision came 129 calendar days after FDA received it (October 17, 2025 to February 23, 2026), and it was substantially equivalent.

Clearance details

Applicant: Skia, Inc.
Product code: Product code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2025-10-17
Decision date: 2026-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seoul, KR

Download summary PDF View on FDA.gov ↗

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K263048 — Syngo Carbon Space (VA4)2026-09-29
K261874 — Syneris PACS v.1.0.1.02026-09-23
K262442 — HipStudio Analysis2026-09-22
K261855 — Elucid PlaqueIQ2026-09-18
K254214 — OOOPDS2026-09-15

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.