510(k) K161518 ยท LLZ System, Image Processing, Radiological
PACS CORE/ENCORE
| Applicant | Compania Mexicana DE Radiologia Cgr, S.A. DE C.V., El Marques Queretaro, MX |
| Decision | Substantially Equivalent, Aug 17, 2016 |
| Received | Jun 2, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161518
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.