510(k) K070094 ยท IYE Accelerator, Linear, Medical
TRILOGY RADIOTHERAPY DELIVERY SYSTEM AND TRILOGY TX DELIVERY SYSTEM
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Feb 9, 2007 |
| Received | Jan 10, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070094
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 15, 2011 | Varian Medical Systems Oncology Systems Varian Radiotherapy delivery system (C-Series Clinac, Trilogy and Novalis Tx), model numbers H14, H17, H18, H23, H26, H29, HCX Terminated |
IYE | None listed |
| Jan 18, 2011 | Varian Medical Systems Oncology Systems C-Series Clinac, Trilogy and Novalis Tx used for SRS treatments, Model Numbers H14, H18, H27, H29, HCX, manufactured by Varian Medical Systems, Palo Alto, CA.
Device is a radiation Therapy accelerat Terminated |
IYE | None listed |
| Jan 8, 2011 | Varian Medical Systems Oncology Systems Varian brand C-series Clinac, Trilogy and Novalis Tx, Software Versions 6.X and 7.X, Model Numbers: H14, H27, H29, HCX, Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alt Terminated |
GKZ | None listed |
| Feb 14, 2008 | Varian Medical Systems Inc Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system: Model: High Energy Clinacs with one or more of the following options:
-- BrainLAB micro MLC,
-- 6MV SRS ph Terminated |
IYE | None listed |
| Feb 14, 2008 | Varian Medical Systems Inc Varian brand Clinac, Accelerator, Linear, Medical charged-particle radiation therapy system;
Model: Low Energy Clinacs with one or more of the following options:
-- BrainLAB micro MLC
-- Stereotacti Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.