510(k) K261331 ยท LNH System, Nuclear Magnetic Resonance Imaging
I-Genius (100019400)
| Applicant | Esaote, S.p.A., Genoa, IT |
| Decision | Substantially Equivalent, Jul 31, 2026 |
| Received | Apr 22, 2026 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K261331
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.