510(k) K202392 ยท KPS System, Tomography, Computed, Emission
SIR-Spheres Microspheres Activity Calculator (SMAC)
| Applicant | Sirtex Medical US Holdings, Inc., Woburn MA, US |
| Decision | Substantially Equivalent, Oct 23, 2020 |
| Received | Aug 21, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202392
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.