510(k) K111543 ยท NOT Microscope, Automated, Image Analysis, Operator Intervention
VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)
| Applicant | Ventana Medical Systems, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Oct 12, 2011 |
| Received | Jun 2, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111543
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.