510(k) K160152 ยท LNH System, Nuclear Magnetic Resonance Imaging
Trillium Oval V 5.1 MRI System
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, May 20, 2016 |
| Received | Jan 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K160152
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.