510(k) K051932 ยท IYE Accelerator, Linear, Medical
ELEKTA SYNERGY; ELEKTA SYNERGY S AND XVIR3.5
| Applicant | Elekta, Inc., Norcross GA, US |
| Decision | Substantially Equivalent, Aug 12, 2005 |
| Received | Jul 13, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051932
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2017 | Elekta, Inc. ELEKTA Digital Accelerator under the following brand names: Elekta Synergy, Synergy S, Synergy Platform, Precise Digital Accelerator, Infinity, Axesse, and Versa HD Terminated |
IYE | None listed |
| Jul 8, 2016 | Elekta, Inc. Medical Linear Accelerator Terminated |
IYE | None listed |
| Feb 10, 2015 | Elekta, Inc. Precise Digital Accelerator
Intended to be used for radiation therapy treatments of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | None listed |
| Mar 7, 2014 | Elekta, Inc. All Elekta digital accelerators with electrons and beam modulator, MLCi/MLCi2, Agility or Asymmetric Heads
Product Usage: Deliver of radiation to defined target volumes Terminated |
IYE | None listed |
| Feb 20, 2014 | Elekta, Inc. Synergy XVI
The Elekta Synergy S is intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | None listed |
| Mar 10, 2013 | Elekta, Inc. Elekta Synergy XVI. Radiation Therapy Digital Imager. Product XVI R3.5.1, R4.2.1, and R4.5.1
Used as part of radiation therapy treatment process. Terminated |
IYE | None listed |
| Sep 19, 2012 | Elekta, Inc. Precise Digital Accelerator
Delivery of radiation to defined target volumes Terminated |
IYE | None listed |
| Nov 29, 2011 | Elekta, Inc. Elekta Synergy XVI 4.5
Product Usage: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | None listed |
| 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 | |
| Mar 22, 2011 | Elekta, Inc. Elekta Synergy XVI R4.5
Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | None listed |
| Feb 15, 2011 | Elekta, Inc. Elekta Synergy XVI
Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | None listed |
| Sep 1, 2010 | Elekta, Inc. Elekta Synergy XVI
Intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | None listed |
| Apr 22, 2010 | Elekta, Inc. Elekta Synergy XVI
The intended use: Radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed medical practitioner. Terminated |
IYE | None listed |
| Apr 16, 2010 | Elekta, Inc. Elekta Synergy XVI Medical Linear Accelerator. Model Numbers R3.5, R4.0 and R4.2. Elekta, Inc. Norcross, GA 30092.
Intended for use as a radiation therapy treatment of malignant neoplastic diseases, Terminated |
IYE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.