510(k) K042720 ยท IYE Accelerator, Linear, Medical
ON-BOARD IMAGER DEVICE
| Applicant | Varian Medical Systems, Palo Alto CA, US |
| Decision | Substantially Equivalent, Oct 29, 2004 |
| Received | Oct 1, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K042720
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2014 | Varian Medical Systems, Inc. Varian On-Board Imager Advanced Imaging System.
The On-Board Imager device is used for verification of correct patient position in relation to isocenter and verification of the treatment fields in re Terminated |
IYE | None listed |
| Apr 24, 2014 | Varian Medical Systems, Inc. On-Board Imager - Exact Arm Elbow Motor Shaft (kVD, kVS, and MV) with ''Type 01" elbow motors.
Product Usage:
The On-Board Imager device is an x-ray device used for evaluation of correct patient po Terminated |
IYE | None listed |
| Aug 31, 2011 | Varian Medical Systems, Inc. Oncology Systems On-Board Imager (OBI) 1.3, 1.4, 1.5; and Trilogy Mx, TrueBeam 1.0, Offline Review 1.0 - 2.0;
Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA
The On-Board Imager Terminated |
IYE | None listed |
| Aug 15, 2008 | Varian Medical Systems Oncology Systems Varian Medical Systems On-Board Imager, Versions 1.0.15 and 1.2.05 Imaging Accessory to Medical Linear Accelerator. The On-Board Imager Device is used for verification of correct patient position in Terminated |
IYE | None listed |
| Aug 29, 2007 | Varian Medical Systems Inc Varian On-Board Imager Device versions 1.2 and 1.3, when used with Cone Beam Computed Tomography. Medical Linear Accelerator. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.