510(k) K141109 ยท NOT Microscope, Automated, Image Analysis, Operator Intervention
APERIO EPATHOLOGY EIHC IVD SYSTEM
| Applicant | Leica Biosystems Imaging, Inc., Vista CA, US |
| Decision | Substantially Equivalent, Jul 29, 2014 |
| Received | Apr 29, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141109
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 4, 2019 | Leica Biosystems Imaging, Inc. Aperio CS2 CE IVD scanner instrument, scanner part #23CS100CE. Terminated |
NOT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.