510(k) K190096 ยท LLZ System, Image Processing, Radiological
R2GATE
| Applicant | Megagen Implant Co., Ltd., Daegu, KR |
| Decision | Substantially Equivalent, Jun 26, 2019 |
| Received | Jan 22, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190096
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.