510(k) K080968 ยท LNH System, Nuclear Magnetic Resonance Imaging
S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA
| Applicant | Esaote, S.p.A., Carmel IN, US |
| Decision | Substantially Equivalent, Apr 29, 2008 |
| Received | Apr 4, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080968
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.