510(k) K232030 ยท LNH System, Nuclear Magnetic Resonance Imaging
Ingenia Elition R5.7.1 SP4 MR Systems
| Applicant | Philips Medical Systems Nederland B.V., Best, NL |
| Decision | Substantially Equivalent, Aug 2, 2023 |
| Received | Jul 7, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K232030
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2026 | Philips North America Philips Ingenia Elition S with MR Elastography (MRE).
1. Model Number (REF): 781357.
2. Model Number (REF): 782106.
3. Model Number (REF): 782137. Open, Classified |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.