510(k) K123808 ยท IYE Accelerator, Linear, Medical
AGILITY
| Applicant | Elekta , Ltd., Crawley, West Sussex, GB |
| Decision | Substantially Equivalent, Apr 4, 2013 |
| Received | Dec 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K123808
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2017 | Elekta Limited Agility with Integrity R3.2 Terminated |
IYE | None listed |
| Mar 6, 2014 | Elekta, Inc. Agility.
Version 3.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators which is associated with Agility collimators. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.