510(k) K052172 ยท LNH System, Nuclear Magnetic Resonance Imaging
HHF1 MAGNETIC RESONANCE IMAGING SYSTEM
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Sep 27, 2005 |
| Received | Aug 9, 2005 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K052172
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Aug 23, 2012 | Hitachi Medical Systems America Inc Hitachi Echelon MRI System/Oasis MRI, Software. These are software controlled MRI devices.
Product Usage:
The Echelon and Oasis MR systems are imaging devices, intended to provide the physician with Terminated |
LNH | None listed |
| Nov 4, 2006 | Hitachi Medical Systems America Inc Hitachi Echelon Magnetic Resonance Imaging System, Serial Number: V-001, equipped with CTL coil type: MR-CTL-150. Terminated |
MOS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.