510(k) K113145 ยท LNH System, Nuclear Magnetic Resonance Imaging
ECHELON OVAL MRI SYSTEM
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, May 1, 2012 |
| Received | Oct 25, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113145
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 23, 2017 | Hitachi Medical Systems America Inc Hitachi Echelon Oval MRI System Terminated |
LNH | None listed |
| Sep 2, 2014 | Hitachi Medical Systems America Inc Hitachi Echelon Oval MRI system is a diagnostic imaging device (one unit per package) and is intended to provide the physician with physiological and clinical information, obtained non-invasively and Terminated |
LNH | None listed |
| Jun 19, 2013 | Hitachi Medical Systems America Inc Echelon, Echelon Oval and Oasis MR imaging device systems; one unit per box.
The Echelon, Echelon Oval and Oasis MR systems are imaging devices, and are intended to provide the physician with physio Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.