510(k) K001643 ยท IYE Accelerator, Linear, Medical
VARIS 1.4G
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Jun 23, 2000 |
| Received | May 30, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001643
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2011 | Varian Medical Systems, Inc. Oncology Systems Varian Medical Systems, Varis Vision - RT Chart version 7.3.10. For radiation therapy. Terminated |
IYE | None listed |
| Nov 9, 2009 | Varian Medical Systems Oncology Systems VARiS 6.2, 6.1 and 6.0 when used with LINK, Model numbers H88 and H85. Manufactured by Varian Medical Systems, Palo Alto, CA. Terminated |
IYE | None listed |
| Aug 27, 2009 | Varian Medical Systems Oncology Systems Varis, Aria Radiation Oncology - Version 8.1.15, 8.5.11, and 8.6.07, Model number HIT-INFSYS, Manufactured by Varian Medical Systems Inc., Palo Alto, CA
The Varis RV function is designed to assist th Terminated |
IYE | None listed |
| Oct 22, 2008 | Varian Medical Systems Oncology Systems Varian RV Software
Varian Treatment for Non-Varian Linacs Version 6.6.5042 and 6.6.5043;
Model Number: H46; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
Desig Terminated |
IYE | None listed |
| Sep 4, 2008 | Varian Medical Systems Oncology Systems Varis Aria Radiation Oncology Version 8.1, manufactured by Varian Medical Systems, Palo Alto, CA The device is designed to assist the operator in providing accurate treatment setups for each patient Terminated |
IYE | None listed |
| Feb 15, 2008 | Varian Medical Systems Inc Varian brand VARiS 1.4g (Medical Charged Particle Radiation Therapy System, Record and Verify System); Linear Accelerator with RTP Exchange v6.2, v6.6, & v8.0, All Models; Varian Medical Systems, Palo Terminated |
IYE | None listed |
| 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 |
| Mar 12, 2003 | Varian Medical Systems Inc VARiS 1.4G and Vision/SomaVision Radiation Therapy Systems; VARiS versions 6.1.33 and 6.2.19 in conjunction with Eclipse 6.x/Soma Vision 6.x Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.