510(k) K062756 ยท NOT Microscope, Automated, Image Analysis, Operator Intervention
PATHIAM IMAGING SOFTWARE FOR HER2/NEU
| Applicant | Bioimagene, Inc., Cupertino CA, US |
| Decision | Substantially Equivalent, Feb 20, 2007 |
| Received | Sep 14, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062756
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.