510(k) K984280 ยท LNH System, Nuclear Magnetic Resonance Imaging
AIRIS II MAGNETIC RESONANCE DIAGNOSTIC DEVICE,INTERVENTIONAL MR PACKAGE
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Feb 8, 1999 |
| Received | Nov 30, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984280
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.