510(k) K032996 ยท IYE Accelerator, Linear, Medical
ELEKTA SYNERGY SYSTEM
| Applicant | Elekta Oncology Systems, Ltd., Norcross GA, US |
| Decision | Substantially Equivalent, Oct 23, 2003 |
| Received | Sep 25, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032996
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2011 | Elekta, Inc. Elekta Synergy
The Elekta Synergy System is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
None listed | |
| Apr 27, 2010 | Elekta, Inc. Elekta Synergy
Intended to be used for radiation therapy treatment of malignant neoplastic diseases. Terminated |
IYE | None listed |
| Mar 18, 2010 | Elekta, Inc. Elekta SL Series/Precise Digital Accelerator.
The product is used with radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.