510(k) K190162 ยท LLZ System, Image Processing, Radiological
SmartCeph
| Applicant | Ortho2, LLC, Ames IA, US |
| Decision | Substantially Equivalent, Oct 17, 2019 |
| Received | Jan 31, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190162
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.