510(k) K161740 ยท KPS System, Tomography, Computed, Emission
D-SPECT Scanner, D-SPECT L Scanner
| Applicant | Spectrum Dynamics Medical, Ltd., North Industrial Park. Caesarea, IL |
| Decision | Substantially Equivalent, Nov 4, 2016 |
| Received | Jun 24, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161740
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.