510(k) K083086 ยท MOS Coil, Magnetic Resonance, Specialty
ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150)
| Applicant | Hitachi Medical Systems America, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Dec 5, 2008 |
| Received | Oct 16, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083086
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.