510(k) K091073 ยท KPS System, Tomography, Computed, Emission
WBR XPRESS.CARDIAC AND XPRESS3.CARDIAC INCLUDING ATTENUATION AND SCATTERING CORRECTIONS
| Applicant | Ultraspect , Ltd., Haifa, IL |
| Decision | Substantially Equivalent, May 14, 2009 |
| Received | Apr 14, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091073
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.