510(k) · Cleared
Recalled · Class II · 2020MRIdian Linac System with 138-leaf Collimator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viewray, Incorporated · IYE Accelerator, Linear, Medical
Cleared on Jun 7, 2017 as substantially equivalent to K162393 (Viewray, Incorporated, 2017) after an 86-day review. Its family tree reaches back 9 generations to 2001. 7 later devices descend from it. It has been recalled 4 times.
- Decided
- Jun 7, 2017
- Review
- 86 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 9 generations to K010975 (2001). 40 ancestors in all, the oldest K864886 (1987). 7 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 5 generations between
- 3 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 2 generations backK102915 Viewray Treatment Planning and Delivery SystemViewray, Incorporated · 2011 · Recalled
- 1 generation backK162393 The ViewRay (MRIdian) Linac SystemViewray, Incorporated · 2017
- This deviceK170751 MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 2017
- Descendant · cites it directly · 3 of its ownK182076 Elekta UnityElekta Limited · 2018 · Recalled
- Descendant · 2 generations on · 2 of its ownK192482 Elekta UnityElekta Limited · 2019 · Recalled
- Descendant · 3 generations on · 1 of its ownK212114 Elekta UnityElekta Solutions AB · 2021 · Recalled
- Descendant · cites it directly · 1 of its ownK181989 MRIdian Linac SystemViewray, Incorporated · 2019 · Recalled
- Descendant · 4 generations on · 0 of its ownK223209 Elekta UnityElekta Solutions AB · 2023
Show all 9 generations
- Root · 9 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 8 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 7 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 6 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 5 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 4 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 3 generations backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- 2 generations backK102915 Viewray Treatment Planning and Delivery SystemViewray, Incorporated · 2011 · Recalled
- 1 generation backK162393 The ViewRay (MRIdian) Linac SystemViewray, Incorporated · 2017
- This deviceK170751 MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K182076Elekta UnityElekta Limited · 2018 · cites it directly3descendants
- K192482Elekta UnityElekta Limited · 2019 · 2 generations on2descendants
- K212114Elekta UnityElekta Solutions AB · 2021 · 3 generations on1descendant
- K181989MRIdian Linac SystemViewray, Incorporated · 2019 · cites it directly1descendant
- K223209Elekta UnityElekta Solutions AB · 2023 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −8 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −7 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −6 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −5 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −4 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −3 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| −2 | K102915 | Viewray Treatment Planning and Delivery System | Viewray, Incorporated | 2011 | 1 |
| −1 | K162393 | The ViewRay (MRIdian) Linac System | Viewray, Incorporated | 2017 | — |
| 0 (this device) | K170751 | MRIdian Linac System with 138-leaf Collimator | Viewray, Incorporated | 2017 | — |
| +1 | K182076 | Elekta Unity | Elekta Limited | 2018 | 4 |
| +2 | K192482 | Elekta Unity | Elekta Limited | 2019 | 3 |
| +3 | K212114 | Elekta Unity | Elekta Solutions AB | 2021 | 1 |
| +1 | K181989 | MRIdian Linac System | Viewray, Incorporated | 2019 | 2 |
| +4 | 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 |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K162393 | The ViewRay (MRIdian) Linac SystemSummary page 4…de: IYE, LNH Device classification name: Accelerator, Linear, Medical 3. Predicate Device to claim substantial equivalence MRIdian Linac System - K162393 4. Description of the Device This submission describes a modification to the currently marketed multi-leaf… | 2017 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 20, 2020 | Class II | Z-0482-2021 | Device Design | There is a potential that components of the receive coil can reach elevated temperatures which has the potential to cause a burn injury to the patient or user. |
| Nov 18, 2019 | Class II | Z-1803-2020 | Software design | Registering dose and structures in the treatment delivery workflow could result in an alignment discrepancy between the imported previously delivered dose and the displayed patient anatomy and structures. The MRIdian TPDS software shows… |
| Mar 18, 2019 | Class II | Z-1251-2019 | Software design | A discrepancy between optimization and planning forward dose calculation between adaptive optimizations and AQA dose calculations can occur. |
| Mar 3, 2019 | Class II | Z-0676-2020 | Error in labeling | Issue with transferring treatment regiment from one system to another. Adequate instructions for transferring treatment plan(s) are not provided within the operator's manual or within the software operating system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 26 of the 40 ancestors have a recall of any class.
- Of its descendants, K182076 (Elekta Limited, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K162393.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 MRIdian Linac system, with magnetic resonance imaging capabilities, is intended to provide stereotactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K170751 · printed Nov 3, 2026
Cite this page
510(k) Report. “K170751: MRIdian Linac System with 138-leaf Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K170751
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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