510(k) K243420 ยท MUE Full Field Digital, System, X-Ray, Mammographic
HESTIA
| Applicant | Genoray Co., Ltd., Seongnam-Si, KR |
| Decision | Substantially Equivalent, Jul 17, 2025 |
| Received | Nov 4, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243420
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.