510(k) K180289 ยท MUJ System, Planning, Radiation Therapy Treatment
3D Bolus Software
| Applicant | 3D Bolus, Inc., Halifax, CA |
| Decision | Substantially Equivalent, Jul 10, 2018 |
| Received | Feb 1, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180289
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.