510(k) K141074 ยท KPS System, Tomography, Computed, Emission
CORTEX ID SUITE
| Applicant | Ge Medical Systems, LLC, Waukesha WI, US |
| Decision | Substantially Equivalent, Sep 18, 2014 |
| Received | Apr 25, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K141074
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.