510(k) K003358 ยท KPS System, Tomography, Computed, Emission
QPS (QUANTITATIVE PERFUSION SPECT), QGS (QUANTITATIVE GATED SPECT)
| Applicant | Smv America, Twinsburg OH, US |
| Decision | Substantially Equivalent, Jan 19, 2001 |
| Received | Oct 26, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003358
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.