510(k) K001163 ยท IXI Block, Beam-Shaping, Radiation Therapy
DMLC IV-ERGO
| Applicant | 3D Line USA, Inc., Baltimore MD, US |
| Decision | Substantially Equivalent, Oct 23, 2000 |
| Received | Apr 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K001163
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 25, 2014 | Elekta, Inc. DMLC IV-ERGO
Product Usage:
Intended for use with rotating gantry linear accelerators to conform radiation dose delivery to geometrical volumes of specific shape containing pathology to be treated so Terminated |
IXI | None listed |
| Sep 4, 2013 | Elekta, Inc. DMLC IV-ERGO - Beam shaping block for Radiation Therapy. Terminated |
IXI | None listed |
| May 25, 2011 | Elekta, Inc. Dynamic Multileaf Collimator (DMLC)
Shapes the radiation beam in treatment therapy. Terminated |
MUJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.