510(k) K191216 · LLZ System, Image Processing, Radiological
Voxel Dosimetry v1.0
| Applicant | Hermes Medical Solutions AB, Stockholm, SE |
| Decision | Substantially Equivalent, Oct 17, 2019 |
| Received | May 6, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K191216
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.