510(k) K050509 ยท KPS System, Tomography, Computed, Emission
LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I
| Applicant | Cti Pet Systems, Inc., Knoxville TN, US |
| Decision | Substantially Equivalent, Mar 25, 2005 |
| Received | Mar 1, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050509
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.