510(k) K945155 ยท LNH System, Nuclear Magnetic Resonance Imaging
AIRIS
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, May 24, 1995 |
| Received | Oct 21, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K945155
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2006 | Hitachi Medical Systems America Inc MRP-7000 and AIRIS Magnetic Resonance Imaging Systems, Software Versions: V7.0A to V7.0J. Terminated |
LNH | None listed |
| Jun 10, 2006 | Hitachi Medical Systems America Inc MRP-7000, AIRIS Magnetic Resonance Imaging Systems Terminated |
LNH | None listed |
| Jan 24, 2006 | Hitachi Medical Systems America Inc The AIRIS 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 MR Terminated |
LNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.