510(k) K242847 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, Oct 23, 2024 |
| Received | Sep 20, 2024 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K242847
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.