K254018
- 510(k) number
- K254018
- Device name
- Portable Dental X-ray Device (GT-1)
- Applicant
- Guilin Refine Medical Instrument Co., Ltd. CN
- Product code
- EHD — Unit, X-Ray, Extraoral With Timer
- Decision date
- 2026-02-19
- Date received
- 2025-12-15
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Flag
- Third-party review
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K254018.pdf
Official FDA record: K254018
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.