510(k) K090417 ยท IXI Block, Beam-Shaping, Radiation Therapy
AXXENT FLEXISHIELD MINI
| Applicant | Xoft, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 23, 2009 |
| Received | Feb 18, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K090417
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 1, 2011 | Xoft Inc. Axxent Flexishield Mini
To shape the beam from a low energy radiation therapy source up to 50kVp. Terminated |
IXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.