510(k) K121278 ยท KPS System, Tomography, Computed, Emission
HERMES MEDICAL IMAGING SUITE V5.2
| Applicant | Hermes Medical Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Dec 18, 2012 |
| Received | Apr 30, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121278
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.