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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / February 2026 / K253486

510(k) cleared

SKIA-Head (Model: SKIA-ST00)

Skia, Inc. · Feb 23, 2026 · K253486

FDA cleared the SKIA-Head (Model: SKIA-ST00) from Skia, Inc. on Feb 23, 2026 under K253486, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code LLZ, System, Image Processing, Radiological, regulated at 21 CFR 892.2050 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Oct 17, 2025. The decision came 129 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Skia, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253486?

K253486 is the FDA 510(k) for SKIA-Head (Model: SKIA-ST00), submitted by Skia, Inc.. FDA's decision date was Feb 23, 2026, under product code LLZ (System, Image Processing, Radiological).

Who makes the SKIA-Head (Model: SKIA-ST00)?

Skia, Inc., based in Seoul, is the applicant of record for K253486.

How long did the K253486 review take?

FDA received the submission on Oct 17, 2025 and issued its decision on Feb 23, 2026, 129 days later.

← All decisions in February 2026