510(k) K001026 ยท KPS System, Tomography, Computed, Emission
3D-MSPECT
| Applicant | The Reagents of the University of Michigan, North Attleboro MA, US |
| Decision | Substantially Equivalent, Jun 20, 2000 |
| Received | Mar 30, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001026
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.