510(k) K011572 ยท KPS System, Tomography, Computed, Emission
QUANTITATIVE GATED SPECT (QGS), QUANTITATIVE PERFUSION SPECT (QPS)
| Applicant | Digirad Corp., San Diego CA, US |
| Decision | Substantially Equivalent, Jun 15, 2001 |
| Received | May 21, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011572
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.