510(k) K180100 ยท LNH System, Nuclear Magnetic Resonance Imaging
MRIaudio PREM System
| Applicant | Mriaudio, Carlsbad CA, US |
| Decision | Substantially Equivalent, Jun 14, 2018 |
| Received | Jan 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180100
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.