510(k) K260795 ยท EHD Unit, X-Ray, Extraoral With Timer
Hand-held Dental X-ray System (HyperLight-M)
| Applicant | Changzhou Sifary Medical Technology Co., Ltd., Changzhou, CN |
| Decision | Substantially Equivalent, Sep 14, 2026 |
| Received | Mar 11, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260795
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.