510(k) K253648 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia, Ingenia CX, Ingenia Elition S/X, Ingenia Ambition S/X, BlueSeal SE/XE/QE, MR 5300 and MR 7700 MR Systems including Upgrades
| Applicant | Philips Medical Systems Nederland B.V., Best, NL |
| Decision | Substantially Equivalent, Feb 23, 2026 |
| Received | Nov 20, 2025 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K253648
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.