510(k) K082368 ยท KPS System, Tomography, Computed, Emission
CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM
| Applicant | Digirad Corp., Poway CA, US |
| Decision | Substantially Equivalent, Sep 12, 2008 |
| Received | Aug 18, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K082368
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.