510(k) K193319 ยท HKI Camera, Ophthalmic, Ac-Powered
XyCAM RI, XyCAM RI System, XyCAM Retinal Imaging System
| Applicant | Vasoptic Medical, Inc., Baltimore MD, US |
| Decision | Substantially Equivalent, Jun 1, 2020 |
| Received | Dec 2, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K193319
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.