SKIA-Head (Model: SKIA-ST00)

FDA 510(k) K253486 · Skia, Inc.

Substantially Equivalent

510(k) numberK253486

Submission

Device name
SKIA-Head (Model: SKIA-ST00)
Applicant
Skia, Inc.
Seoul, KR
Received
October 17, 2025
Decision date
February 23, 2026
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

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Questions and answers

When was SKIA-Head (Model: SKIA-ST00) cleared by the FDA?

SKIA-Head (Model: SKIA-ST00) (K253486) received a 510(k) decision of Substantially Equivalent on February 23, 2026, 129 days after the submission was received.

What is the product code of K253486?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.