510(k) K913641 ยท KPS System, Tomography, Computed, Emission
SOPHY NXT
| Applicant | Sopha Medical Systems, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Dec 17, 1991 |
| Received | Aug 13, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K913641
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.