510(k) K111676 ยท IXI Block, Beam-Shaping, Radiation Therapy
APEX
| Applicant | Elekta Limited, West Sussex, GB |
| Decision | Substantially Equivalent, Sep 30, 2011 |
| Received | Jun 15, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111676
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 26, 2013 | Elekta, Inc. Elekta, Apex add-on Micro MLC, collimator for radiation therapy. Terminated |
IXI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.