# K051932: Elekta Synergy; Elekta Synergy S and XVIR3.5

- Pathway: 510(k) (Special)
- Applicant: Elekta, Inc.
- Decided: Aug 12, 2005 after 30 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K963624 (1996). 2 ancestors in all.
17 later devices descend from it; 3 cite it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032996: Elekta Synergy System, Elekta Oncology Systems, Ltd. (2003) Summary page 1.

## Most influential descendants
- K100115: XVI R4.5 (2010), 9 descendants of its own
- K131965: XVI R5.0 (2013), 8 descendants of its own
- K151561: Leksell Gamma Knife Icon (2015), 4 descendants of its own
- K182138: Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD (2018), 3 descendants of its own
- K160440: Leksell Gamma Knife Icon (2016), 3 descendants of its own

## Recalls of this device
- Dec 1, 2017 · Class II · Z-2840-2018: There is a potential for an uncontrolled extension of iViewGT / XVI detector arms.
- Jul 8, 2016 · Class II · Z-2721-2016: There have been instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bolts.
- Jan 7, 2015 · Class II · Z-1088-2015: Elekta has identified a batch of securing bolts that fix the Gantry counter frame weight stack may fail.
- Nov 25, 2013 · Class II · Z-1061-2014: Potential collision risk when using XVI and external beam shaping devices.
- May 28, 2013 · Class II · Z-1065-2014: Customers are resetting the default values outside recommended factory settings.
- Dec 19, 2012 · Class II · Z-0931-2013: The DICOM tags do not contain sufficient information for XVI to identify the different volumes that have the same name.
- Aug 6, 2012 · Class II · Z-2405-2012: There have been a small number of instances in hospitals where the joint between the drive gear and the gantry base drive wheel has become loose, leading to fatigue failure of some of the securing bol
- May 6, 2011 · Not classified · Z-3079-2011: A small number of the Modular Reverse Diodes (D1A), a component in the equipment room of the Elekta Linear Accelerator, have ruptured.
- Mar 9, 2011 · Not classified · Z-0305-2012: If "Confirm" or "Unconfirm" settings are clicked during the "Terminated Checking" phase of treatment delivery, Desktop Pro cancels the loaded beam and sets the Beam MUs to zero. Desktop Pro then sends
- Jan 5, 2011 · Not classified · Z-1252-2011: Flexmap calibration did not cover the full 360 degrees of gantry rotation (0 to 355 degrees) and that this caused an isocenter displacement with 2D PlanarView images required at 180 to -180.
- Oct 25, 2010 · Not classified · Z-1723-2011: If another patient is selected on the imaging system (XVI) release 4.5) during the transmission of end of treatment data from Desktop Pro R7.01 to R&V system, the XVI information is prioritized and th
- Sep 1, 2010 · Not classified · Z-0350-2011: It is possible to do couch corrections twice if both Couch Move Assistant in MOSAIQ and Remote Automatic Table in XVI are configured when in SYNERGISTIQ mode.
- Dec 12, 2008 · Not classified · Z-1405-2010: It is possible that two (or more) CT reference data sets are necessary for one patient, for example, if you have to scan a patient during breath hold and then again during free breathing.
- Sep 19, 2007 · Not classified · Z-1411-2010: Firm became aware of a failure in the position detection system which could result in incorrect positioning of the detector in the longitudinal or lateral direction.

## Indications for use
The Elekta Synergy®, Elekta Synergy® S, and XVI R3.5 are intended to be used for radiation therapy treatment of malignant neoplastic diseases, as determined by a licensed physician.

Source page: https://510kreport.com/device/K051932
Methodology: https://510kreport.com/methodology