510(k) K254265 ยท LLZ System, Image Processing, Radiological
Helion Viewer Suite
| Applicant | Videomed Srl ( a Baxter Healthcare Corp company), Limena (Pd), IT |
| Decision | Substantially Equivalent, May 27, 2026 |
| Received | Dec 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254265
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.