510(k) K051282 ยท NOT Microscope, Automated, Image Analysis, Operator Intervention
VENTANA IMAGE ANALYSIS SYSTEM - HER2/NEU
| Applicant | Tripath Imaging, Inc., Durham NC, US |
| Decision | Substantially Equivalent, Aug 16, 2005 |
| Received | May 17, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051282
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.