510(k) K072279 ยท LNH System, Nuclear Magnetic Resonance Imaging
MAGNETIC RESONANCE DIAGNOSTIC DEVICE
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Sep 21, 2007 |
| Received | Aug 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K072279
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 6, 2017 | Hitachi Medical Systems America Inc Hitachi Oasis MRI System - C-Spine Coil Terminated |
LNH | None listed |
| Aug 10, 2015 | Hitachi Medical Systems America Inc Oasis Coil Extension Cable used with Hitachi Oasis MRI System
Product Usage:
The Oasis MR system is an imaging device and is intended to provide the physician with physiological and clinical informat Terminated |
MOS | 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 |
| 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 |
| May 4, 2010 | Hitachi Medical Systems America Inc Hitachi Oasis Magnetic Resonance Scanners Software V1.0C
The intended use: The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal s Terminated |
IWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.