510(k) · Cleared
ClearedPrecise Treatment System; Synergy platform; Synergy; Infinity; VersaHD
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eleckta Limited · IYE Accelerator, Linear, Medical
Cleared on Sep 5, 2018 as substantially equivalent to K123808 (Elekta, Ltd., 2013) and 1 other predicate after a 29-day review. Its family tree reaches back 8 generations to 1995. 3 later devices descend from it.
- Decided
- Sep 5, 2018
- Review
- 29 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K926449 (1995). 31 ancestors in all, the oldest K864886 (1987). 3 later devices descend from it, 1 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 backK123808 AgilityElekta, Ltd. · 2013 · Recalled
- This deviceK182138 Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHDEleckta Limited · 2018
- Descendant · cites it directly · 2 of its ownK192242 Synergy Platform, Synergy, Infinity, VersaHDElekta Limited · 2019
- Descendant · 2 generations on · 1 of its ownK210500 Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK252188 EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA…Elekta Solutions AB · 2026
Most influential descendants
Showing 3 of 3 · See all- K192242Synergy Platform, Synergy, Infinity, VersaHDElekta Limited · 2019 · cites it directly2descendants
- K210500Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HDElekta Limited · 2021 · 2 generations on1descendant
- K252188EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy)…Elekta Solutions AB · 2026 · 3 generations on0descendants
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 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
| 0 (this device) | K182138 | Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD | Eleckta Limited | 2018 | — |
| +1 | K192242 | Synergy Platform, Synergy, Infinity, VersaHD | Elekta Limited | 2019 | — |
| +2 | K210500 | Elekta Synergy, Elekta Harmony, Elekta Infinity, Versa HD | Elekta Limited | 2021 | 10 |
| +3 | 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 |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 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? (2)
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 |
|---|---|---|---|
| * | K123808 | AgilitySummary page 4…Accelerator, Linear, Medical, 21CFR 892.5050 Product Code: 90 IYE Predicate Device: Elekta Limited, K123808 Agility, K051932 Elekta Synergy Product Description: The Elekta Medical Linear Accelerator system is an image guided Radiatio… | 2013 |
| * | K051932 | Elekta Synergy; Elekta Synergy S and XVIR3.5Summary page 4…Accelerator, Linear, Medical, 21CFR 892.5050 Product Code: 90 IYE Predicate Device: Elekta Limited, K123808 Agility, K051932 Elekta Synergy Product Description: The Elekta Medical Linear Accelerator system is an image guided Radiation Therapy device… | 2005 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192242 | Synergy Platform, Synergy, Infinity, VersaHD | 2019 | 2 |
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 23 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 24 of the 31 ancestors have a recall of any class.
- Of its descendants, K192242 (Elekta Limited, 2019) has gone furthest, with 2 descendants of its own.
- 1 other device also cites its predicate K123808.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 is indicated to assist a licensed practitioner in the delivery of radiation to defined target volumes (e.g. lesions, arterio-venous malformations, malignant and benign tumors), whilst sparing surrounding normal tissue and critical organs from excess radiation 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K182138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182138: Precise Treatment System; Synergy platform; Synergy; Infinity; VersaHD.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182138
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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