510(k) K170434 ยท LLZ System, Image Processing, Radiological
Enterprise Imaging XERO Viewer 8.1
| Applicant | Agfa Healthcare N.V., Mortsel, BE |
| Decision | Substantially Equivalent, Jul 3, 2017 |
| Received | Feb 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170434
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 10, 2024 | Agfa Healthcare NV Enterprise Imaging XERO Viewer- software application used for reference and diagnostic viewing of multispecialty medical imaging and non-imaging data .
Enterprise Imaging XERO Viewer 8.0.0, 8.0.1, 8. Open, Classified |
LLZ | None listed |
| Jan 20, 2023 | Agfa Healthcare NV Agfa HealthCare Enterprise Imaging XERO Viewer Open, Classified |
LLZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.