510(k) K003849 ยท KPS System, Tomography, Computed, Emission
GE ADVANCE NXI PET SYSTEM
| Applicant | Ge Medical Systems, Inc., Milwaukee WI, US |
| Decision | Substantially Equivalent, Dec 22, 2000 |
| Received | Dec 12, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K003849
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.