510(k) K010137 ยท KPS System, Tomography, Computed, Emission
ORBITER II CCI/SPECT ORBITER II CCI/SPECT
| Applicant | Siemens Medical Solutions USA, Inc., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, Feb 13, 2001 |
| Received | Jan 17, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010137
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.