510(k) K190056 ยท NFJ System, Image Management, Ophthalmic
KOWA VK-2s
| Applicant | Kowa Co. Ltd. Chofu, Chofu City, JP |
| Decision | Substantially Equivalent, Feb 12, 2019 |
| Received | Jan 11, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190056
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 3, 2020 | Kowa Optimed Inc Kowa VK-2s software Version 10.0.4.0, Product code 04987646809500 installed on Kowa nonmyd WX Retinal Cameras - Product Usage: is indicated for acquiring, displaying and storing image data from KOWA s Terminated |
NFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.