510(k) K083533 ยท LNH System, Nuclear Magnetic Resonance Imaging
ECHELON C MRI SYSTEM
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Feb 17, 2009 |
| Received | Nov 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083533
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2021 | Hitachi Healthcare Americas Corporation ECHELON MRI System Terminated |
LNH | None listed |
| Mar 23, 2017 | Hitachi Medical Systems America Inc Hitachi Echelon 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.