FDA 510(k)

SKIA-Head (Model: SKIA-ST00)

K-Number: K253486 · 2026-02-23

Decision Date2026-02-23

Product CodeLLZ

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SKIA-Head (Model: SKIA-ST00) is the device name listed in this FDA 510(k) record. The listed applicant is Skia, Inc.. It received FDA 510(k) clearance on 2026-02-23 under 510(k) number K253486. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SKIA-Head (Model: SKIA-ST00)?

SKIA-Head (Model: SKIA-ST00) is a medical device that received FDA 510(k) clearance on 2026-02-23. The listed applicant is Skia, Inc.. The 510(k) number is K253486.

When did SKIA-Head (Model: SKIA-ST00) receive FDA 510(k) clearance?

SKIA-Head (Model: SKIA-ST00) received FDA 510(k) clearance on 2026-02-23, under 510(k) number K253486.

Who is the listed applicant for SKIA-Head (Model: SKIA-ST00)?

The FDA 510(k) record lists Skia, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SKIA-Head (Model: SKIA-ST00)?

The FDA product code for SKIA-Head (Model: SKIA-ST00) is LLZ.

Related Devices (Code: LLZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLC K261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific Corporation K262143ImageGrid StreamVueCandelis, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.