510(k) K946334 ยท KPS System, Tomography, Computed, Emission
GALEN
| Applicant | Medimage, Inc., Ann Arbor MI, US |
| Decision | Substantially Equivalent, Mar 23, 1995 |
| Received | Dec 29, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K946334
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.