510(k) K163539 ยท LLZ System, Image Processing, Radiological
Ez3D-i / E3
| Applicant | Ewoosoft Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, Dec 23, 2016 |
| Received | Dec 16, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163539
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.