510(k) K080784 ยท KPS System, Tomography, Computed, Emission
WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE
| Applicant | Ultraspect , Ltd., Haifa, IL |
| Decision | Substantially Equivalent, Apr 2, 2008 |
| Received | Mar 20, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080784
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.