510(k) K181318 ยท LLZ System, Image Processing, Radiological
ONIS-PACS
| Applicant | Digitalcore Co., Ltd., Tokyo, JP |
| Decision | Substantially Equivalent, Aug 13, 2018 |
| Received | May 18, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181318
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.