510(k) K082244 ยท KPS System, Tomography, Computed, Emission
PCA-8000A, MARK 11, PET / CT SYSTEM
| Applicant | Toshiba America Medical Systems, In.C, Tustin CA, US |
| Decision | Substantially Equivalent, Aug 21, 2008 |
| Received | Aug 8, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082244
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.