510(k) K970627 ยท KPS System, Tomography, Computed, Emission
E. CAM COINCIDENCE MODE (CM)
| Applicant | Siemens Medical Solutions USA, Inc., Hoffman Estates IL, US |
| Decision | Substantially Equivalent, Sep 4, 1997 |
| Received | Feb 19, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970627
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.