510(k) K974212 ยท LNH System, Nuclear Magnetic Resonance Imaging
AIRIS II
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Feb 9, 1998 |
| Received | Nov 10, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974212
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 14, 2006 | Hitachi Medical Systems America Inc Hitachi AIRIS II MRI System Terminated |
LNH | None listed |
| Jun 10, 2006 | Hitachi Medical Systems America Inc AIRIS II, Altaire Nuclear Magnetic Resonance Imaging Device Systems Terminated |
LNH | None listed |
| May 31, 2006 | Hitachi Medical Systems America Inc Magnetic Resonance Imaging Device Terminated |
LNH | None listed |
| Jan 24, 2006 | Hitachi Medical Systems America Inc The AIRIS II MR System is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non invasively and without the use of ionizing radiation. The 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.