510(k) K050479 ยท IYE Accelerator, Linear, Medical
4D INTEGRATED TREATMENT CONSOLE
| Applicant | Varian Medical Systems, Palo Alto CA, US |
| Decision | Substantially Equivalent, Mar 24, 2005 |
| Received | Feb 24, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050479
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2006 | Varian Medical Systems Inc 4D Integrated Treatment Console and Varis 1.4g Medical Charged Particle Radiation Therapy System;
All 4D Integrated treatment console versions 8.0.15 and below (excluding v7.0.31) and all Varis Non-V Terminated |
IYE | None listed |
| Aug 5, 2006 | Varian Medical Systems Oncology Systems Varis Vision Treatment 6.6/RTP Exchange/Siemens Accelerators Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.