510(k) K010975 ยท IYE Accelerator, Linear, Medical
ECLIPSE 6.5
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, May 2, 2001 |
| Received | Apr 2, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K010975
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2009 | Varian Medical Systems Oncology Systems Varian Medical Systems Eclipse treatment planning system, Model Number H48, versions 6.5/7.x and Inspiration 8.0. Terminated |
IYE | None listed |
| Sep 17, 2008 | Varian Medical Systems Oncology Systems Varian Medical Systems Eclipse device, model H48, Version 6.5 is used to plan photon and electron radiation therapy treatments. Terminated |
IYE | None listed |
| Jan 18, 2006 | Varian Medical Systems Inc Varian brand Radiation Therapy Linear Accelerator VARiS;
VARiS Vision v6.5 up to and including v7.3.10 SP2 (used with BrainLab M3 MultiLeaf Collimator (MLC); Eclipse (used with BrainLab M3 MLC); Acui Terminated |
IWB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.