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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 / K254018

510(k) cleared

Portable Dental X-ray Device (GT-1)

Guilin Refine Medical Instrument Co., Ltd. · Feb 19, 2026 · K254018

FDA cleared the Portable Dental X-ray Device (GT-1) from Guilin Refine Medical Instrument Co., Ltd. on Feb 19, 2026 under K254018, a traditional 510(k) reviewed through the Third Party Review Program. The device falls under product code EHD, Unit, X-Ray, Extraoral With Timer, regulated at 21 CFR 872.1800 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Dec 15, 2025. The decision came 66 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Guilin Refine Medical Instrument Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254018?

K254018 is the FDA 510(k) for Portable Dental X-ray Device (GT-1), submitted by Guilin Refine Medical Instrument Co., Ltd.. FDA's decision date was Feb 19, 2026, under product code EHD (Unit, X-Ray, Extraoral With Timer).

Who makes the Portable Dental X-ray Device (GT-1)?

Guilin Refine Medical Instrument Co., Ltd., based in Guangxi, is the applicant of record for K254018.

How long did the K254018 review take?

FDA received the submission on Dec 15, 2025 and issued its decision on Feb 19, 2026, 66 days later.

← All decisions in February 2026