510(k) K981790 ยท IYE Accelerator, Linear, Medical
IVIEW ELECTRONIC PORTAL IMAGING DEVICE (EPID) MODEL NUMBER IVEW
| Applicant | Elekta Oncology Systems, Ltd., Atlanta GA, US |
| Decision | Substantially Equivalent, Aug 7, 1998 |
| Received | May 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K981790
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 26, 2010 | Elekta, Inc. iView GT Electronic Portal Imaging Device, used with radiation therapy treatments. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.