Cleared Traditional

SKIA-Head (Model: SKIA-ST00)

K253486 · Skia, Inc. · Radiology

Feb 2026

Decision

129d

Days

Class 2

Risk

About This 510(k) Submission

K253486 is an FDA 510(k) clearance for the SKIA-Head (Model: SKIA-ST00), a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Skia, Inc. (Seoul, KR). The FDA issued a Cleared decision on February 23, 2026, 129 days after receiving the submission on October 17, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K253486 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 17, 2025
Decision Date	February 23, 2026
Days to Decision	129 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF