510(k) K223909 ยท LLZ System, Image Processing, Radiological
R2GATE Lite TM
| Applicant | Megagen Implant Co., Ltd., Deagu, KR |
| Decision | Substantially Equivalent, Oct 20, 2023 |
| Received | Dec 29, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223909
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.