Cleared Traditional

Portable Dental X-ray Device (GT-1)

K254018 · Guilin Refine Medical Instrument Co., Ltd. · Radiology

Feb 2026

Decision

66d

Days

Class 2

Risk

About This 510(k) Submission

K254018 is an FDA 510(k) clearance for the Portable Dental X-ray Device (GT-1), a Unit, X-ray, Extraoral With Timer (Class II — Special Controls, product code EHD), submitted by Guilin Refine Medical Instrument Co., Ltd. (Guangxi, CN). The FDA issued a Cleared decision on February 19, 2026, 66 days after receiving the submission on December 15, 2025. This device falls under the Radiology review panel. Regulated under 21 CFR 872.1800.

Submission Details

510(k) Number	K254018 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 15, 2025
Decision Date	February 19, 2026
Days to Decision	66 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF