510(k) K100115 ยท IYE Accelerator, Linear, Medical
XVI R4.5
| Applicant | Elekta , Ltd., Crawley W. Sussex, GB |
| Decision | Substantially Equivalent, Mar 10, 2010 |
| Received | Jan 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100115
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 20, 2014 | Elekta, Inc. Synergy XVI
XVI can incorrectly calculate the target position of the treatment table, because of an error that does not occur very frequently. This is the sequence of events when this error occurs - Terminated |
IYE | None listed |
| Feb 21, 2012 | Elekta, Inc. Elekta Synergy XVI 4.5 and R4.6
To be used as part of radiation therapy treatment process. Terminated |
IYE | None listed |
| Dec 1, 2011 | Elekta, Inc. Elekta Synergy XVI R.4.5 and R4.6
ProducT Usage: To be used as part of radiation therapy treatment process. Terminated |
IYE | None listed |
| Dec 1, 2011 | Elekta, Inc. Elekta Synergy XVI X-ray Volume Imaging System
To be used as part of radiation therapy treatment process. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.