510(k) K132816 ยท MUJ System, Planning, Radiation Therapy Treatment
ONCENTRA BRACHY
| Applicant | Nucletron B.V., Rice Lake WI, US |
| Decision | Substantially Equivalent, Jun 13, 2014 |
| Received | Sep 9, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132816
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 15, 2022 | Elekta, Inc. Oncentra Brachy radiation therapy planning system software. Open, Classified |
MUJ | None listed |
| Oct 13, 2021 | Elekta, Inc. Oncentra Brachy users using version 4.0 and above with Applicator Modeling license 170283-00 Open, Classified |
MUJ | None listed |
| Aug 10, 2017 | Nucletron BV Oncentra Brachy 4.5 radiation therapy software The firm name on the label is Nucletron B.V.
Oncentra is a radiation therapy planning software designed to analyze and plan radiation treatments in t Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.