510(k) K080271 ยท JAK System, X-Ray, Tomography, Computed
INREACH SYSTEM
| Applicant | Superdimension, Ltd., Plymouth MN, US |
| Decision | Substantially Equivalent, Mar 31, 2008 |
| Received | Feb 1, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080271
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.