510(k) K061613 ยท NQN Microscope, Automated, Image Analysis, Immunohistochemistry,Operator Intervention,Nuclear Intensity & Percent Positivity
VENTANA IMAGE ANALYSIS SYSTEM - PATHWAY HER2 (4B5)
| Applicant | Tripath Imaging, Durham NC, US |
| Decision | Substantially Equivalent, Jan 10, 2007 |
| Received | Jun 9, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2008 | Ventana Medical Systems Inc Ventana Image Analysis System (VIAS) - PATHWAY anti-HER-2/neu (4B5) primary antibody with software version 2.3.0.2, Model Number: VIAS-799-10000-00, Pathology Image Analysis System, Ventana Medical Sy Terminated |
NQN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.