510(k) K260227 ยท KPR System, X-Ray, Stationary
EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50H
| Applicant | DRTECH Corporation, Seongnam-Si, KR |
| Decision | Substantially Equivalent, Sep 8, 2026 |
| Received | Jan 26, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K260227
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.