510(k) K170978 · LNH System, Nuclear Magnetic Resonance Imaging
Embrace Neonatal MRI System
| Applicant | Aspect Imaging, Ltd., Industrial Area Hevel ModiIn., IL |
| Decision | Substantially Equivalent, Jul 19, 2017 |
| Received | Apr 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170978
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.