510(k) K213438 ยท MUJ System, Planning, Radiation Therapy Treatment
3D Bolus Software Application, 3D Brachy Software Application, Patient-Matched 3D Printed Radiation Therapy Accessory
| Applicant | Adaptiiv, Halifax, CA |
| Decision | Substantially Equivalent, Jan 19, 2022 |
| Received | Oct 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213438
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.