510(k) K161246 ยท LLZ System, Image Processing, Radiological
Ez3D-i / E3
| Applicant | Ewoosoft Co., Ltd., Hwaseong-Si, KR |
| Decision | Substantially Equivalent, May 31, 2016 |
| Received | May 3, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K161246
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.