510(k) · Cleared
ClearedEMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Elekta Solutions AB · IYE Accelerator, Linear, Medical
Cleared on Jan 15, 2026 as substantially equivalent to K210500 (Elekta Limited, 2021) after a 185-day review. Its family tree reaches back 11 generations to 1995.
- Decided
- Jan 15, 2026
- Review
- 185 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K926449 (1995). 34 ancestors in all, the oldest K864886 (1987). No later device cites it as a predicate yet.
- Root · 11 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 7 generations between
- 3 generations backK182138 Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited · 2018
- 2 generations backK192242 Synergy Platform, Synergy, Infinity, VersaHDElekta Limited · 2019
- 1 generation backK210500 Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited · 2021 · Recalled
- This deviceK252188 EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA…Elekta Solutions AB · 2026
Show all 11 generations
- Root · 11 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 10 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 9 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 8 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 7 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 6 generations backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- 5 generations backK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- 4 generations backK123808 AgilityElekta, Ltd. · 2013 · Recalled
- 3 generations backK182138 Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited · 2018
- 2 generations backK192242 Synergy Platform, Synergy, Infinity, VersaHDElekta Limited · 2019
- 1 generation backK210500 Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited · 2021 · Recalled
- This deviceK252188 EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA…Elekta Solutions AB · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −10 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −9 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −8 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −7 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −6 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| −5 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| −4 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
| −3 | K182138 | Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD | Eleckta Limited | 2018 | — |
| −2 | K192242 | Synergy Platform, Synergy, Infinity, VersaHD | Elekta Limited | 2019 | — |
| −1 | K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | Elekta Limited | 2021 | 10 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDSummary page 5…n name: Accelerator, Linear, Medical Product Code: IYE III. PREDICATE DEVICE Predicate Device #: K210500 Predicate Trade Name: Elekta Synergy, Elekta Harmony, Elekta Infinity,… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 31 years and passes through 7 companies; a new generation was cleared every 2.3 years on median.
- 25 of the 34 ancestors have a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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. It is intended to…
Read the full statement (245 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. It is 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 and Elekta Harmony Pro are 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 and Elekta Evo are 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252188: EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252188
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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