510(k) K233530 ยท KPR System, X-Ray, Stationary
EXSYS DEXi (EXSYS DEXi-D401S-FRM); EXSYS DEXi (EXSYS DEXi-A401S-FRM); EXSYS DEXi (EXSYS DEXi-D402S-FRM); EXSYS DEXi (EXSYS DEXi-A402S-FRM); EXSYS DEXi (EXSYS DEXi-D401P-FRM); EXSYS DEXi (EXSYS DEXi-A401P-FRM); EXSYS DEXi (EXSYS DEXi-D402P-FRM); EXSYS DEXi (EXSYS DEXi-A402P-FRM); EXSYS DEXi (EXSYS DE
| Applicant | DRTECH Corporation, Seongnam-Si, KR |
| Decision | Substantially Equivalent, Jul 26, 2024 |
| Received | Nov 2, 2023 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K233530
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.