510(k) K081188 ยท IYE Accelerator, Linear, Medical
TRILOGY WITH EXTERNAL SYSTEM GATING INTERFACE
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Jul 14, 2008 |
| Received | Apr 28, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081188
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 14, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand Clinac, Trilogy, Novalis Tx, Unique, linear accelerators; Model Number: H14, H18, H29, Reference/FSCA Identifier: CP-08881; Product is manufactured and distributed by Varian Medical Syst Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.