510(k) K032232 ยท LNH System, Nuclear Magnetic Resonance Imaging
AIRIS ELITE MAGNETIC RESONANCE IMAGING DEVICE
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Sep 29, 2003 |
| Received | Jul 21, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K032232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2006 | Hitachi Medical Systems America Inc Magnetic Resonance Imaging Device Terminated |
LNH | None listed |
| Jun 14, 2005 | Hitachi Medical Systems America Inc Hitachi AIRIS Elite Magnetic Resonance Imaging Device Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.