510(k) K153547 ยท LNH System, Nuclear Magnetic Resonance Imaging
ECHELON Oval V 5.1 MRI System
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Mar 31, 2016 |
| Received | Dec 11, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K153547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2017 | Hitachi Medical Systems America Inc Hitachi Oasis MRI System Terminated |
LNH | None listed |
| Mar 23, 2017 | Hitachi Medical Systems America Inc Hitachi Echelon Oval MRI System Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.