510(k) K080585 ยท IYE Accelerator, Linear, Medical
DESKTOP PRO
| Applicant | Elekta , Ltd., West Sussex, GB |
| Decision | Substantially Equivalent, Jun 11, 2008 |
| Received | Mar 3, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K080585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 6, 2014 | Elekta, Inc. Desktop Pro TM linear accelerator control software intended to assist a licensed practitioner in the delivery of radiation to defined target volumes. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.