510(k) K261788 ยท LLZ System, Image Processing, Radiological
Eden PACS
| Applicant | Higia., Inc. d/b/a Eden, Wilmington DE, US |
| Decision | Substantially Equivalent, Oct 21, 2026 |
| Received | May 29, 2026 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K261788
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.