510(k) K002420 ยท LNH System, Nuclear Magnetic Resonance Imaging
HITACHI ALTAIRE
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Oct 17, 2000 |
| Received | Aug 8, 2000 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K002420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2008 | Hitachi Medical Systems America Inc Altaire MRI System Emergency Rundown Switch Unit (ERDU) is intended to provide the physician with physiological and clinical information obtained non-invasive and without the use of ionizing radiation Terminated |
LNH | None listed |
| Sep 26, 2007 | Hitachi Medical Systems America Inc Altaire Shoulder Coil, an accessory to the Altaire MRI system. The shoulder coil is a two-channel, receive only coil that functions at 29.641 MHz band. It consists of a cable and a coil (imaging) bo Terminated |
LNH | None listed |
| Jun 10, 2006 | Hitachi Medical Systems America Inc Hitachi Altaire Magnetic Resonance Imaging 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 |
| Jun 14, 2005 | Hitachi Medical Systems America Inc Hitachi Altaire Magnetic Resonance Imaging Device. Terminated |
LNH | None listed |
| May 17, 2005 | Hitachi Medical Systems America Inc Altaire, Magnetic Resonance Imaging Device. Terminated |
LNH | None listed |
| May 3, 2005 | Hitachi Medical Systems America Inc Altaire, 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.