510(k) · Cleared
Recalled · Class II · 2019Elekta Unity
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 Dec 4, 2018 as substantially equivalent to K170751 (Viewray, Incorporated, 2017) after a 125-day review. Its family tree reaches back 10 generations to 2001. 3 later devices descend from it. It has been recalled 4 times.
- Decided
- Dec 4, 2018
- Review
- 125 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 10 generations to K010975 (2001). 41 ancestors in all, the oldest K864886 (1987). 3 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 6 generations between
- 3 generations backK102915 Viewray Treatment Planning and Delivery SystemViewray, Incorporated · 2011 · Recalled
- 2 generations backK162393 The ViewRay (MRIdian) Linac SystemViewray, Incorporated · 2017
- 1 generation backK170751 MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 2017 · Recalled
- This deviceK182076 Elekta UnityElekta Limited · 2018
- Descendant · cites it directly · 2 of its ownK192482 Elekta UnityElekta Limited · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK212114 Elekta UnityElekta Solutions AB · 2021 · Recalled
- Descendant · 3 generations on · 0 of its ownK223209 Elekta UnityElekta Solutions AB · 2023
Show all 10 generations
- Root · 10 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 9 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 8 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 7 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 6 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 5 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 4 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 3 generations backK102915 Viewray Treatment Planning and Delivery SystemViewray, Incorporated · 2011 · Recalled
- 2 generations backK162393 The ViewRay (MRIdian) Linac SystemViewray, Incorporated · 2017
- 1 generation backK170751 MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 2017 · Recalled
- This deviceK182076 Elekta UnityElekta Limited · 2018
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −9 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −8 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −7 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −6 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −5 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −4 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −3 | K102915 | Viewray Treatment Planning and Delivery System | Viewray, Incorporated | 2011 | 1 |
| −2 | K162393 | The ViewRay (MRIdian) Linac System | Viewray, Incorporated | 2017 | — |
| −1 | K170751 | MRIdian Linac System with 138-leaf Collimator | Viewray, Incorporated | 2017 | 4 |
| 0 (this device) | K182076 | Elekta Unity | Elekta Limited | 2018 | — |
| +1 | K192482 | Elekta Unity | Elekta Limited | 2019 | 3 |
| +2 | K212114 | Elekta Unity | Elekta Solutions AB | 2021 | 1 |
| +3 | K223209 | Elekta Unity | Elekta Solutions AB | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 2 | 0 |
| 1997 | 2 | 0 |
| 1999 | 2 | 0 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 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 |
|---|---|---|---|
| * | K170751 | MRIdian Linac System with 138-leaf CollimatorSummary page 4…t Code: IYE, LNH Device classification name: Accelerator, Linear, Medical Predicate Device: ViewRay (MRIdian) Linac System, K170751 Product Description: Elekta Unity is a multifunctional digital linear accelerator designed to assist licensed medical practitio… | 2017 |
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 |
|---|---|---|---|
| K192482 | Elekta Unity | 2019 | 2 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2019 | Class II | Z-1980-2019 | Software design | The QA software solution to perform the MR to MV alignment check, does not display the stored MR to MV offset values. The user is unable to independently inspect the values during their QA. |
| Apr 3, 2019 | Class II | Z-1297-2019 | Labeling design | There is no warning in the Elekta Unity manual for the administration of gadolinium-based or other contrast agents for imaging or image guidance purposes has not been validated. |
| Mar 12, 2019 | Class II | Z-1109-2019 | Software design | Users need to be aware when using these protocols for daily on line plan adaptation that: 1) The images acquired using these protocols do not represent the average position of the anatomy during the respiratory motion cycle. The images… |
| Jan 4, 2019 | Class II | Z-0706-2019 | Under Investigation by firm | In rare circumstances, due to reasons such as inadequate hospital facility maintenance, water leakage, and weakening of speaker fixings during the lifetime of the system, the speakers can become dislodged and be pulled into the bore. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 1.5 years on median.
- 27 of the 41 ancestors have a recall of any class.
- Of its descendants, K192482 (Elekta Limited, 2019) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K170751.
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?
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan. Elekta Unity is intended for use with the compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system…
Read the full statement (105 words)
Elekta Unity using Magnetic Resonance Imaging is indicated for radiation therapy treatments and stereotactic radiation treatments of malignant and benign diseases anywhere in the body as determined by a licensed medical practitioner in accordance with a defined treatment plan.
Elekta Unity is intended for use with the compatible Treatment Planning and Oncology Information Systems.
The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that produces cross-sectional images in any orientation of the internal structure of the whole body before, during, and after the radiotherapy treatment. Images provide information that may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.
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/K182076 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182076: Elekta Unity.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K182076
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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