510(k) K091132 ยท IYE Accelerator, Linear, Medical
4D INTEGRATED TREATMENT CONSOLE
| Applicant | Varian Medical Systems, Palo Alto CA, US |
| Decision | Substantially Equivalent, Jun 17, 2009 |
| Received | Apr 20, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Varian brand 4D Integrated Treatment Console (4DITC) v10.2.3, Reference/FSCA Identifier: CP-06873,
Model Number: H51, distributed by and manufactured by:
Varian Medical Systems Inc., Palo Alto, CA
Th Terminated |
IYE | None listed |
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems 4D Integrated Treatment Console (4DITC) TrueBeam Linear Accelerator
Varian Medical Systems, Palo Alto, CA.
The 4DITC is designed to interface to the Varian Clinac Treatment Control System for the pur Terminated |
IYE | None listed |
| Sep 14, 2011 | Varian Medical Systems, Inc. Oncology Systems 4D Integrated Treatment Console v 8.6 with ARIA RT Chart v8.5, all of 4DITC v 8.3;
Varian Medical Systems, Palo Alto, CA
Designed to assist the operator of a radiation therapy device in providing the Terminated |
IYE | None listed |
| Apr 29, 2011 | Varian Medical Systems, Inc. Oncology Systems The 4D Integrated Treatment Console; Model Number: H51; Reference: 4DITC versions 8.6 and below; File Reference: CP-2007-0288; Product is manufactured and distributed by Varian Medical Systems Inc., P Terminated |
IYE | None listed |
| Jan 10, 2011 | Varian Medical Systems Oncology Systems 4D Integrated Treatment Console, versions: 8.0.12, 8.0.23 SP2, 8.1 SP2, 8.1.1.3, 8.1.1.4, 8.1.2, 8.1.3, 8.1.4, 8.3, 8.6, 8.6.1, 8.6.2, 8.8.0; Model Number: H51; Distributed and manufactured by: Varian Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.