510(k) K001681 ยท KPS System, Tomography, Computed, Emission
POSITRACE DUAL MODE PET/CT ONCOLOGY SYSTEM
| Applicant | Smv America, Twinsburg OH, US |
| Decision | Substantially Equivalent, Aug 25, 2000 |
| Received | Jun 1, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001681
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.