510(k) K200078 ยท LLZ System, Image Processing, Radiological
VARO Plan
| Applicant | 3D Industrial Imaging Co., Ltd., Seoul, KR |
| Decision | Substantially Equivalent, Apr 10, 2020 |
| Received | Jan 14, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200078
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.