510(k) K061545 ยท KPS System, Tomography, Computed, Emission
SCENIUM 1.1
| Applicant | Siemens Molecular Imaging, Ltd., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, Jun 30, 2006 |
| Received | Jun 5, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K061545
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.