510(k) K212587 ยท IYX Camera, Scintillation (Gamma)
3D-RD-S
| Applicant | Radiopharmaceutical Imaging and Dosimetry, LLC, Baltimore MD, US |
| Decision | Substantially Equivalent, Feb 22, 2023 |
| Received | Aug 16, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212587
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.