510(k) K212230 ยท LLZ System, Image Processing, Radiological
TruSPECT Radiological Image Processing Station
| Applicant | Spectrum Dynamics Medical, Ltd., Caesarea, IL |
| Decision | Substantially Equivalent, Aug 16, 2021 |
| Received | Jul 16, 2021 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K212230
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.