510(k) K954143 ยท KPS System, Tomography, Computed, Emission
HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS
| Applicant | Hitachi Medical Corp. of America, Tarrytown NY, US |
| Decision | Substantially Equivalent, Dec 22, 1995 |
| Received | Sep 1, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954143
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.