510(k) K191585 ยท LLZ System, Image Processing, Radiological
iNtuition-Structural Heart Module
| Applicant | Terarecon,Inc., Foster City CA, US |
| Decision | Substantially Equivalent, Jul 12, 2019 |
| Received | Jun 14, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191585
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.