510(k) K043381 ยท KPS System, Tomography, Computed, Emission
INFINIA LIGHTSPEED
| Applicant | Ge Medical Systems F.I. Haifa, Tirat Hacarmel, IL |
| Decision | Substantially Equivalent, Dec 23, 2004 |
| Received | Dec 9, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043381
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.