510(k) K121328 ยท IYE Accelerator, Linear, Medical
AGILITY
| Applicant | Elekta , Ltd., Crawley, West Sussex, GB |
| Decision | Substantially Equivalent, Jun 12, 2012 |
| Received | May 3, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K121328
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2014 | Elekta, Inc. Agility.
Version 3.0 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 |
| May 25, 2013 | Elekta, Inc. Integrity 3.0
Product Usage:
The Agility multileaf collimator is indicated for use when additional flexibility is required in conforming the radiation beam to the anatomy to be exposed. Terminated |
IYE | None listed |
| Sep 10, 2012 | Elekta, Inc. Multileaf Collimator
To be used for single or multiple fractions, delivered as static and/or dynamic beams of radiation, in all areas of the body where such treatment is indicated. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.