510(k) K254277 ยท LNH System, Nuclear Magnetic Resonance Imaging
Embrace Neonatal MRI System
| Applicant | Aspect Imaging, Ltd., Shoham, IL |
| Decision | Substantially Equivalent, Mar 13, 2026 |
| Received | Dec 30, 2025 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K254277
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.