510(k) · Cleared
Recalled · Class II · 2017Elekta Synergy; Elekta Synergy S and XVIR3.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta, Inc. · IYE Accelerator, Linear, Medical
Cleared on Aug 12, 2005 as substantially equivalent to K032996 (Elekta Oncology Systems, Ltd., 2003) after a 30-day review. Its family tree reaches back 2 generations to 1996. 17 later devices descend from it. It has been recalled 14 times.
- Decided
- Aug 12, 2005
- Review
- 30 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 14
- Predicates
- 1
Its longest line of descent runs back 2 generations to K963624 (1996). 17 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 1 generation backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- This deviceK051932 Elekta Synergy; Elekta Synergy S and XVIR3.5Elekta, Inc. · 2005
- Descendant · cites it directly · 9 of its ownK100115 XVI R4.5Elekta, Ltd. · 2010 · Recalled
- Descendant · 2 generations on · 8 of its ownK131965 XVI R5.0Elekta Limited · 2013
- Descendant · 3 generations on · 4 of its ownK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
- Descendant · cites it directly · 3 of its ownK182138 Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited · 2018
- Descendant · 4 generations on · 3 of its ownK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K100115XVI R4.5Elekta, Ltd. · 2010 · cites it directly9descendants
- K131965XVI R5.0Elekta Limited · 2013 · 2 generations on8descendants
- K151561Leksell Gamma Knife IconElekta Instrument AB · 2015 · 3 generations on4descendants
- K182138Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited · 2018 · cites it directly3descendants
- K160440Leksell Gamma Knife IconElekta Instrument AB · 2016 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −1 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| 0 (this device) | K051932 | Elekta Synergy; Elekta Synergy S and XVIR3.5 | Elekta, Inc. | 2005 | — |
| +1 | K100115 | XVI R4.5 | Elekta, Ltd. | 2010 | 4 |
| +2 | K131965 | XVI R5.0 | Elekta Limited | 2013 | — |
| +3 | K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015 | 1 |
| +1 | K182138 | Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD | Eleckta Limited | 2018 | — |
| +4 | K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K032996 | Elekta Synergy SystemSummary page 1…ar Accelerator (with Patient Imaging) Classification Name: Medical Linear Accelerator Accessory 90 lYE Predicate Device: Elekta Synergy® System (K032996) Product Description: This Premarket Notification Special 510(k) describes modifications to the Elekta Synergy® Syst… | 2003 |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 1, 2017 | Class II | Z-2840-2018 | Component design/selection | There is a potential for an uncontrolled extension of iViewGT / XVI detector arms. |
| Jul 8, 2016 | Class II | Z-2721-2016 | Other | 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 | Other | 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 | Software design | Potential collision risk when using XVI and external beam shaping devices. |
| May 28, 2013 | Class II | Z-1065-2014 | Device Design | Customers are resetting the default values outside recommended factory settings. |
| Dec 19, 2012 | Class II | Z-0931-2013 | Software design | 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 | Nonconforming Material/Component | 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 bolts. |
| May 6, 2011 | Not classified | Z-3079-2011 | Other | 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 | Software design | 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 the delivered MUs to MOSAIQ a a zero… |
| Jan 5, 2011 | Not classified | Z-1252-2011 | Other | 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 | Other | 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 the end of treatment data is never… |
| Sep 1, 2010 | Not classified | Z-0350-2011 | Other | 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 | Software design | 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 | Device Design | 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. |
The 5 latest of 14 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 3 companies; a new generation was cleared every 6.9 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K100115 (Elekta, Ltd., 2010) has gone furthest, with 9 descendants of its own.
- 2 other devices also cite its predicate K032996.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051932 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051932: Elekta Synergy; Elekta Synergy S and XVIR3.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051932
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026