510(k) K150069 ยท LLZ System, Image Processing, Radiological
Fine Structure Analysis(fineSA)
| Applicant | Acuitas Medical , Ltd., Swansea, GB |
| Decision | Substantially Equivalent, May 22, 2015 |
| Received | Jan 13, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150069
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.