510(k) K254018 ยท EHD Unit, X-Ray, Extraoral With Timer
Portable Dental X-ray Device (GT-1)
| Applicant | Guilin Refine Medical Instrument Co., Ltd., Guangxi, CN |
| Decision | Substantially Equivalent, Feb 19, 2026 |
| Received | Dec 15, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254018
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.