510(k) K213883 ยท PSY Whole Slide Imaging System
NanoZoomer S360MD Slide scanner system
| Applicant | Hamamatsu Photonics K.K., Hamamatsu City, JP |
| Decision | Substantially Equivalent, Sep 27, 2022 |
| Received | Dec 13, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213883
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2023 | Hamamatsu Corporation NanoZoomer S360MD Slide scanner system-automated system for creating, viewing, and managing digital slides. The NanoZoomer System creates diagnostic-quality digital images of glass slides containing f Open, Classified |
PSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.