510(k) K172110 ยท LNH System, Nuclear Magnetic Resonance Imaging
ECHELON OVAL V6.0A MRI System
| Applicant | Hitachi Healthcare Americas Corporation, Twinsburg OH, US |
| Decision | Substantially Equivalent, Jan 11, 2018 |
| Received | Jul 13, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172110
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2021 | Hitachi Healthcare Americas Corporation 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.