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

Substantially Equivalent

Skia, Inc.

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

Clearance details

Applicant: Skia, Inc.
Product code: Code LLZ
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 ↗

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.