510(k) K041519 ยท IYE Accelerator, Linear, Medical
MODIFICATION TO: ON-BOARD IMAGER DEVICE
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Aug 4, 2004 |
| Received | Jun 7, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041519
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.