510(k) K112613 ยท IYE Accelerator, Linear, Medical
INTEGRITY(TM)
| Applicant | Elekta Limited, Crawley, West Sussex, GB |
| Decision | Substantially Equivalent, Dec 16, 2011 |
| Received | Sep 7, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112613
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 20, 2017 | Elekta Limited Integrity R1.2 Terminated |
IYE | None listed |
| Apr 2, 2014 | Elekta, Inc. Integrity 1.1.
Integrity is the interface and control software for the Elekta range of medical digital linear accelerators and is intended to assist a licensed practitioner in the delivery of radiati Terminated |
IYE | None listed |
| Mar 6, 2014 | Elekta, Inc. Integrity.
Version 1.1 of the Integrity interface and control software for the Elekta range of medical digital linear accelerators. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.