510(k) · Cleared
Recalled · Class II · 2013XVI R4.5
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta, Ltd. · IYE Accelerator, Linear, Medical
Cleared on Mar 10, 2010 as substantially equivalent to K051932 (Elekta, Inc., 2005) after a 54-day review. Its family tree reaches back 3 generations to 1996. 9 later devices descend from it. It has been recalled 4 times.
- Decided
- Mar 10, 2010
- Review
- 54 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K963624 (1996). 9 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK963624 Philips Sli Series Linear AcceleratorPhilips Medical Systems, Inc. · 1996 · Recalled
- 2 generations backK032996 Elekta Synergy SystemElekta Oncology Systems, Ltd. · 2003 · Recalled
- 1 generation backK051932 Elekta Synergy; Elekta Synergy S and XVIR3.5Elekta, Inc. · 2005 · Recalled
- This deviceK100115 XVI R4.5Elekta, Ltd. · 2010
- Descendant · cites it directly · 8 of its ownK131965 XVI R5.0Elekta Limited · 2013
- Descendant · 2 generations on · 4 of its ownK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
- Descendant · 3 generations on · 3 of its ownK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
- Descendant · 4 generations on · 2 of its ownK173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
- Descendant · 5 generations on · 1 of its ownK222047 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell…Elekta Solutions AB · 2022
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K131965XVI R5.0Elekta Limited · 2013 · cites it directly8descendants
- K151561Leksell Gamma Knife IconElekta Instrument AB · 2015 · 2 generations on4descendants
- K160440Leksell Gamma Knife IconElekta Instrument AB · 2016 · 3 generations on3descendants
- K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018 · 4 generations on2descendants
- K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB · 2022 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K963624 | Philips Sli Series Linear Accelerator | Philips Medical Systems, Inc. | 1996 | 2 |
| −2 | K032996 | Elekta Synergy System | Elekta Oncology Systems, Ltd. | 2003 | 3 |
| −1 | K051932 | Elekta Synergy; Elekta Synergy S and XVIR3.5 | Elekta, Inc. | 2005 | 14 |
| 0 (this device) | K100115 | XVI R4.5 | Elekta, Ltd. | 2010 | — |
| +1 | K131965 | XVI R5.0 | Elekta Limited | 2013 | — |
| +2 | K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015 | 1 |
| +3 | K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016 | 1 |
| +4 | K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018 | — |
| +5 | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife -… | Elekta Solutions AB | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K051932 | Elekta Synergy; Elekta Synergy S and XVIR3.5Summary page 1…red at the point of treatment and their content to be spatially related to the forthcoming MV treatment, as previously cleared under Control Number K051932. There has been no change made to the underlying technological characteristics of the product. Substantial Eq… | 2005 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131965 | XVI R5.0 | 2013 | 8 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 25, 2013 | Class II | Z-1059-2014 | Software design | XVI can incorrectly calculate the target position of the treatment table. |
| Jan 26, 2012 | Not classified | Z-1066-2012 | Software design | If a user, using an on-line correction protocol, clicks the accept correction button, an approval dialog box appears. If cancel is selected, the table correction values return to their initial values, but the image panes continue to… |
| Oct 20, 2011 | Not classified | Z-0342-2012 | Nonconforming Material/Component | A small number of sites have experienced situations with kV generator transformers overheating due to a diode failure on the interface board. |
| Oct 14, 2011 | Not classified | Z-0320-2012 | Software design | The software did not operate as expected. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K131965 (Elekta Limited, 2013) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K051932.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
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 X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of radiation therapy treatment process, as determined by a licensed medical practitioner. XVI, is intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement. Symmetry™…
Read the full statement (111 words)
The Elekta X-Ray Volume Imaging system, XVI, is an electronic imaging device (EID), designed to be used with the Elekta range of medical linear accelerators and intended to be used as part of radiation therapy treatment process, as determined by a licensed medical practitioner.
XVI, is intended to confirm patient positioning and support decision making in response to target displacement resulting from organ deformation and anatomical movement.
Symmetry™ is a software option within XVI that can be used to acquire and display volumetric images of sequential phases of the breathing cycle for the evaluation of respiration induced motion, to assist in identification of appropriate target locations within anatomical structures in motion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K100115 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100115: XVI R4.5.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100115
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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