510(k) K072468 ยท KPS System, Tomography, Computed, Emission
MODIFICATION TO D-SPECT CARDIAC SCANNER SYSTEM
| Applicant | Spectrum Dynamics , Ltd., Kfar Saba, IL |
| Decision | Substantially Equivalent, Oct 1, 2007 |
| Received | Sep 4, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2012 | Spectrum Dynamics D-SPECT Cardiac Scanner System -- COMMON/USUAL NAME: Emission Computed Tomography System --- SPECTRUM DYNAMICS --- Spectrum Dynamics (Israel) Ltd. 22 Bareket St. North Industrial Park, P.O. Box 3033, Terminated |
KPS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.