510(k) K143485 ยท IYE Accelerator, Linear, Medical
iGuide 2.1
| Applicant | Medical Intelligence Medizintechnik GmbH, Schwabmuenchen, DE |
| Decision | Substantially Equivalent, Mar 4, 2015 |
| Received | Dec 8, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K143485
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 19, 2017 | Elekta, Inc. iGUIDE Software 2.2
Product Usage:
Control of accurate patient positioning with assistance of a 30 Tracking System in a radiotherapy environment. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.