510(k) K083649 ยท KPS System, Tomography, Computed, Emission
CARDIUS 3 X-ACT
| Applicant | Digirad Corp., Poway CA, US |
| Decision | Substantially Equivalent, Mar 9, 2009 |
| Received | Dec 9, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083649
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.