510(k) K202267 ยท KXK Source, Brachytherapy, Radionuclide
Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles
| Applicant | Isoray Medical, Inc., Richland WA, US |
| Decision | Substantially Equivalent, Dec 31, 2020 |
| Received | Aug 11, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K202267
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.