510(k) · Cleared
ClearedElekta Unity
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 Feb 23, 2023 as substantially equivalent to K212114 (Elekta Solutions AB, 2021) after a 129-day review. Its family tree reaches back 13 generations to 2001.
- Decided
- Feb 23, 2023
- Review
- 129 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K010975 (2001). 44 ancestors in all, the oldest K864886 (1987). No later device cites it as a predicate yet.
- Root · 13 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 9 generations between
- 3 generations backK182076 Elekta UnityElekta Limited · 2018 · Recalled
- 2 generations backK192482 Elekta UnityElekta Limited · 2019 · Recalled
- 1 generation backK212114 Elekta UnityElekta Solutions AB · 2021 · Recalled
- This deviceK223209 Elekta UnityElekta Solutions AB · 2023
Show all 13 generations
- Root · 13 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 12 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 11 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 10 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 9 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 8 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 7 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 6 generations backK102915 Viewray Treatment Planning and Delivery SystemViewray, Incorporated · 2011 · Recalled
- 5 generations backK162393 The ViewRay (MRIdian) Linac SystemViewray, Incorporated · 2017
- 4 generations backK170751 MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 2017 · Recalled
- 3 generations backK182076 Elekta UnityElekta Limited · 2018 · Recalled
- 2 generations backK192482 Elekta UnityElekta Limited · 2019 · Recalled
- 1 generation backK212114 Elekta UnityElekta Solutions AB · 2021 · Recalled
- This deviceK223209 Elekta UnityElekta Solutions AB · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −12 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −11 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −10 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −9 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −8 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −7 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −6 | K102915 | Viewray Treatment Planning and Delivery System | Viewray, Incorporated | 2011 | 1 |
| −5 | K162393 | The ViewRay (MRIdian) Linac System | Viewray, Incorporated | 2017 | — |
| −4 | K170751 | MRIdian Linac System with 138-leaf Collimator | Viewray, Incorporated | 2017 | 4 |
| −3 | K182076 | Elekta Unity | Elekta Limited | 2018 | 4 |
| −2 | K192482 | Elekta Unity | Elekta Limited | 2019 | 3 |
| −1 | K212114 | Elekta Unity | Elekta Solutions AB | 2021 | 1 |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K212114 | Elekta UnitySummary page 4…Medical charged-particle radiation therapy system Product Code: IYE, LNH III. PREDICATE DEVICE Predicate Device: Elekta Unity (K212114) IV. INTENDED USE Elekta Unity is intended for radiation therapy treatments and stereotactic radiation treatmen… | 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 22 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 30 of the 44 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. 2023, 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 compatible Treatment Planning and Oncology Information Systems. The Elekta Unity 1.5T MR scanner is a magnetic resonance imaging system that…
Read the full statement (126 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 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.
When interpreted by a trained physician magnetic resonance images acquired before, during, and after the radiotherapy treatment yield information that can be useful in diagnosis and may assist therapy planning, patient positioning and treatment delivery related to radiation oncology.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223209 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223209: 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/K223209
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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