K254018 is an FDA 510(k) clearance for the Portable Dental X-ray Device (GT-1). This device is classified as 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 FDA review panel. Regulated under 21 CFR 872.1800.
| 510(k) Number | K254018 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (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 |
| Product Code | EHD - Unit, X-ray, Extraoral With Timer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1800 |