510(k) K970990 ยท LNH System, Nuclear Magnetic Resonance Imaging
GYREX PRIMA 1TG 1.0T MRI SYSTEM
| Applicant | Elscint Mr, Inc., Fort Collins CO, US |
| Decision | Substantially Equivalent, Aug 25, 1997 |
| Received | Mar 18, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970990
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.