510(k) K182016 ยท LLZ System, Image Processing, Radiological
Simplicit90Y
| Applicant | Mirada Medical, Ltd., Oxford, GB |
| Decision | Substantially Equivalent, Dec 6, 2018 |
| Received | Jul 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K182016
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.