510(k) K212116 ยท QKB Radiological Image Processing Software For Radiation Therapy
VBrain-OAR
| Applicant | Vysioneer, Inc., Cambridge MA, US |
| Decision | Substantially Equivalent, Oct 12, 2021 |
| Received | Jul 7, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212116
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.