510(k) K091209 ยท IYE Accelerator, Linear, Medical
PORTALVISION ADVANCED IMAGING
| Applicant | Varian Medical Systems, Inc., Palo Alto CA, US |
| Decision | Substantially Equivalent, Jun 23, 2009 |
| Received | Apr 24, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K091209
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2012 | Varian Medical Systems, Inc. Oncology Systems Portal Vision, R-Arm with 4D Integrated Treatment Console;
Varian Medical Systems. Palo Alto, CA.
The Portal Vision device is used for verification of the treatment field and shielding block in relat Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.