510(k) K961597 ยท KPS System, Tomography, Computed, Emission
GATED MIBI 3-D EJECTION FRACTION PROCESSING
| Applicant | Trionix Research Laboratory, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Sep 4, 1996 |
| Received | Apr 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K961597
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.