510(k) K001334 ยท LNH System, Nuclear Magnetic Resonance Imaging
HITACHI AIRIS II
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Jul 6, 2000 |
| Received | Apr 27, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001334
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 19, 2010 | Hitachi Medical Systems America Inc Hitachi AIRIS, AIRIS II, AIRIS Elite MRI Scanner Compensation Coil. Part numbers: MR-FC-2EO, MR-FC-3EO Terminated |
MOS | None listed |
| Jun 14, 2006 | Hitachi Medical Systems America Inc Hitachi AIRIS II MRI System Terminated |
LNH | None listed |
| Jun 14, 2005 | Hitachi Medical Systems America Inc Hitachi AIRIS II 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.