510(k) K110507 ยท KPS System, Tomography, Computed, Emission
CARDIAC SCANNER AND PROCESSING SYSTEM
| Applicant | Spectrum Dynamics (Israel) , Ltd., Zichron Yaacov, IL |
| Decision | Substantially Equivalent, Jul 13, 2011 |
| Received | Feb 22, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K110507
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.