510(k) · Cleared
ClearedXVI R5.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Limited · IYE Accelerator, Linear, Medical
Cleared on Sep 25, 2013 as substantially equivalent to K100115 (Elekta, Ltd., 2010) and 2 other predicates after a 90-day review. Its family tree reaches back 8 generations to 1995. 8 later devices descend from it.
- Decided
- Sep 25, 2013
- Review
- 90 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K926449 (1995). 35 ancestors in all, the oldest K864886 (1987). 8 later devices descend from it, 3 citing it directly.
- Root · 8 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 7 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 6 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 5 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 4 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 3 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 2 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 1 generation backK123291 TruebeamVarian Medical Systems, Inc. · 2012
- This deviceK131965 XVI R5.0Elekta Limited · 2013
- Descendant · cites it directly · 4 of its ownK151561 Leksell Gamma Knife IconElekta Instrument AB · 2015 · Recalled
- Descendant · 2 generations on · 3 of its ownK160440 Leksell Gamma Knife IconElekta Instrument AB · 2016 · Recalled
- Descendant · 3 generations on · 2 of its ownK173789 Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018
- Descendant · 4 generations on · 1 of its ownK222047 Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell…Elekta Solutions AB · 2022
- Descendant · cites it directly · 1 of its ownK161400 ImagingRing SystemMedphoton GmbH · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K151561Leksell Gamma Knife IconElekta Instrument AB · 2015 · cites it directly4descendants
- K160440Leksell Gamma Knife IconElekta Instrument AB · 2016 · 2 generations on3descendants
- K173789Leksell Gamma Knife Perfexion, Leksell Gamma Knife IconElekta Instrument AB · 2018 · 3 generations on2descendants
- K222047Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife - Elekta…Elekta Solutions AB · 2022 · 4 generations on1descendant
- K161400ImagingRing SystemMedphoton GmbH · 2016 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −7 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −6 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −5 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −4 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −3 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −2 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −1 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| 0 (this device) | K131965 | XVI R5.0 | Elekta Limited | 2013 | — |
| +1 | K151561 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2015 | 1 |
| +2 | K160440 | Leksell Gamma Knife Icon | Elekta Instrument AB | 2016 | 1 |
| +3 | K173789 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon | Elekta Instrument AB | 2018 | — |
| +4 | K222047 | Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon, Leksell Gamma Knife -… | Elekta Solutions AB | 2022 | — |
| +1 | K161400 | ImagingRing System | Medphoton GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K100115 | XVI R4.5Summary page 2…XVI R4.5 TVrueiam) Vero (Varian) (BrainLab) Control Number K---------- K 100115 K123291 K122451 Visualize bony NoCagYeYsYs anatomy on image NoCagYeYsYs… | 2010 |
| * | K123291 | TruebeamSummary page 1…Medical Linear Accelerator Accessory, 21 CFR 892.5050 Product Code: lYE Predicate Device: Elekta XVI (K(1001 15), Varian TrueBeam (K1 23291), Brainlab ExacTrac Vero (K122451)' Product Description: This Traditional 510(k) describes mo… | 2012 |
| * | K122451 | Exactrac VeroSummary page 1…: lYE Predicate Device: Elekta XVI (K(1001 15), Varian TrueBeam (K1 23291), Brainlab ExacTrac Vero (K122451)' Product Description: This Traditional 510(k) describes modifications made to the XVI kilo-voltage imaging accessory of the… | 2012 |
What descends from it? (8)
3 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
- 24 of the 35 ancestors have a recall of any class.
- Of its descendants, K151561 (Elekta Instrument AB, 2015) has gone furthest, with 4 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 the radiation therapy treatment process for single or multiple fractions, of static and/or dynamic treatments, in gated or un-gated deliveries, in all areas of the body where such image guidance is determined by a licensed physician. It provides real-time 2D, 3D &…
Read the full statement (248 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 the radiation therapy treatment process for single or multiple fractions, of static and/or dynamic treatments, in gated or un-gated deliveries, in all areas of the body where such image guidance is determined by a licensed physician.
It provides real-time 2D, 3D & 4D image guidance before, during and after treatment delivery, and is intended to support confirmation of patient positioning, monitoring and management of internal motion, and decision making in response to target position, size, shape and displacement resulting from organ deformation and anatomical movement in relation to surrounding critical structures.
XVI facilitates precise and accurate dose placement, and patient set-up correction, through visualization of internal anatomy including target, critical structures and soft tissue with or without the use of implanted markers.
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.
The Elekta digital linear accelerator can be used for treatment that includes but is not limited to malignant and benign brain tumors, brain metastases, spine lesions treated using SRS, squamous cell carcinoma of the head and neck, lung, breast, pancreatic, hepatic malignancies treated using SBRT, prostate, and bone metastases.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131965 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131965: XVI R5.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131965
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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