510(k) K053086 ยท KPS System, Tomography, Computed, Emission
MIE - GAMMA CAMERA SYSTEMS
| Applicant | Mie America, Inc., Elk Grove Village IL, US |
| Decision | Substantially Equivalent, Jan 27, 2006 |
| Received | Nov 2, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053086
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.