510(k) · Cleared
Recalled · Class II · 2025Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD
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 Jun 11, 2021 as substantially equivalent to K192242 (Elekta Limited, 2019) after a 109-day review. Its family tree reaches back 10 generations to 1995. 1 later device descends from it. It has been recalled 10 times.
- Decided
- Jun 11, 2021
- Review
- 109 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 10
- Predicates
- 1
Its longest line of descent runs back 10 generations to K926449 (1995). 33 ancestors in all, the oldest K864886 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 10 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 6 generations between
- 3 generations backK123808 AgilityElekta, Ltd. · 2013 · Recalled
- 2 generations backK182138 Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited · 2018
- 1 generation backK192242 Synergy Platform, Synergy, Infinity, VersaHDElekta Limited · 2019
- This deviceK210500 Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited · 2021
- Descendant · cites it directly · 0 of its ownK252188 EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA…Elekta Solutions AB · 2026
Show all 10 generations
- Root · 10 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 9 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 8 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 7 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 6 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 5 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 4 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 3 generations backK123808 AgilityElekta, Ltd. · 2013 · Recalled
- 2 generations backK182138 Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited · 2018
- 1 generation backK192242 Synergy Platform, Synergy, Infinity, VersaHDElekta Limited · 2019
- This deviceK210500 Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited · 2021
Most influential descendants
Showing 1 of 1 · See all- K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −9 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −8 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −7 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −6 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −5 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −4 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −3 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
| −2 | K182138 | Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD | Eleckta Limited | 2018 | — |
| −1 | K192242 | Synergy Platform, Synergy, Infinity, VersaHD | Elekta Limited | 2019 | — |
| 0 (this device) | K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | Elekta Limited | 2021 | — |
| +1 | K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta… | Elekta Solutions AB | 2026 | — |
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 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K192242 | Synergy Platform, Synergy, Infinity, VersaHDSummary page 4…Accelerator, Linear, Medical, 21CFR 892.5050 Product Code: IYE III. PREDICATE DEVICE K192242 IV. DEVICE DESCRIPTION The Elekta Medical Linear Accelerator (EMLA) system is an image guided Radiation Therap… | 2019 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K252188 | EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)… | 2026 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 14, 2025 | Class II | Z-1164-2026 | Process control | Due to a manufacturing issue and electrical grounding of systems. |
| Oct 25, 2023 | Class II | Z-0443-2024 | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of… |
| Oct 25, 2023 | Class II | Z-0444-2024 | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of… |
| Oct 25, 2023 | Class II | Z-0447-2024 | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of… |
| Oct 25, 2023 | Class II | Z-0442-2024 | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of… |
| Oct 25, 2023 | Class II | Z-0445-2024 | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of… |
| Oct 25, 2023 | Class II | Z-0446-2024 | Under Investigation by firm | Elekta has identified that if the microswitch within the middle arm is incorrectly setup, there is a potential for an uncontrolled extension of iViewGT / XVI detector arms. When the detector arm is fully deployed there is no risk of… |
| May 5, 2023 | Class II | Z-1665-2023 | Under Investigation by firm | A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601 |
| Sep 28, 2021 | Class II | Z-0115-2022 | Nonconforming Material/Component | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter. |
| Sep 17, 2021 | Class II | Z-0116-2022 | Under Investigation by firm | There is a risk that the Diode D1 in the Modulator can fail in a destructive manner when removed from the machine, and that the protective tube surrounding the diode may fail to contain the ejected matter. |
The 5 latest of 10 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 26 years and passes through 6 companies; a new generation was cleared every 2.3 years on median.
- 24 of the 33 ancestors have a recall of any class.
- Of its descendants, K252188 (Elekta Solutions AB, 2026) has gone furthest, with 0 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. 2021, 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 Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner. It is intended to assist a licensed medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation. −Elekta Synergy and Elekta Harmony are the default entry-level configurations. They are…
Read the full statement (238 words)
The Elekta Medical Linear Accelerator (EMLA) is intended to be used for external beam radiation therapy (EBRT) treatments as determined by a licensed medical practitioner.
It is intended to assist a licensed medical practitioner in the delivery of EBRT to defined target volumes, while sparing surrounding normal tissue and critical organs from excess radiation.
−Elekta Synergy and Elekta Harmony are the default entry-level configurations. They are intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, and hypofractionation in all areas of the body where such treatment is indicated.
−Elekta Infinity is the default mid-level configuration. It is intended to be used for single or multiple fractions using standard dose fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT; stereotactic ablative radiotherapy – SABR) in all areas of the body where such treatment is indicated.
−Versa HD is the default high-level configuration. It is intended to be used for single or multiple fractions using standard fractionation, hyperfractionation, hypofractionation and stereotactic delivery (stereotactic body radiation therapy – SBRT; stereotactic ablative radiotherapy – SABR; stereotactic radio surgery - SRS) in all areas of the body where such treatment is indicated and for the treatment of functional disorders, such as trigeminal neuralgia.
The EMLA is indicated for the delivery of curative and palliative intent EBRT to Adult and Pediatric patients with primary benign and malignant tumor and metastasis (or secondaries) anywhere in the body.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K210500 · printed Nov 6, 2026
Cite this page
510(k) Report. “K210500: Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K210500
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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