510(k) K964265 ยท KPS System, Tomography, Computed, Emission
CARDIAC TRIAD NUCLEAR IMAGING SINGLE PHOTON EMISSION COMPUTED TOMOGRAPHY SYSTEM
| Applicant | Trionix Research Laboratory, Inc., Twinsburg OH, US |
| Decision | Substantially Equivalent, Nov 12, 1996 |
| Received | Oct 24, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K964265
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.