510(k) K003264 ยท KPS System, Tomography, Computed, Emission
QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION
| Applicant | Ge Medical Systems F.I. Haifa, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Dec 21, 2000 |
| Received | Oct 18, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003264
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.