510(k) · Cleared
Recalled · Class II · 2021MRIdian Linac System
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 Feb 20, 2019 as substantially equivalent to K170751 (Viewray, Incorporated, 2017) and 1 other predicate after a 209-day review. Its family tree reaches back 10 generations to 2001. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Feb 20, 2019
- Review
- 209 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 10 generations to K010975 (2001). 41 ancestors in all, the oldest K864886 (1987). 1 later device descends 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 deviceK181989 MRIdian Linac SystemViewray, Incorporated · 2019
- Descendant · cites it directly · 0 of its ownK212958 MRIdian Linac SystemViewray, Incorporated · 2021
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 deviceK181989 MRIdian Linac SystemViewray, Incorporated · 2019
Most influential descendants
Showing 1 of 1 · See all- K212958MRIdian Linac SystemViewray, Incorporated · 2021 · cites it directly0descendants
View 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) | K181989 | MRIdian Linac System | Viewray, Incorporated | 2019 | — |
| +1 | K212958 | MRIdian Linac System | Viewray, Incorporated | 2021 | — |
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 |
|---|---|---|
| 2021 | 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 |
|---|---|---|---|
| * | K170751 | MRIdian Linac System with 138-leaf CollimatorSummary page 4…ccelerator, Linear, Medical; System, Nuclear Magnetic Resonance Imaging 3. Substantial Equivalence Predicate device: MRIdian Linac System - K170751 Reference device: MRIdian Linac System – K162393 ViewRay Headquarters… | 2017 |
| * | K162393 | The ViewRay (MRIdian) Linac SystemSummary page 4…etic Resonance Imaging 3. Substantial Equivalence Predicate device: MRIdian Linac System - K170751 Reference device: MRIdian Linac System – K162393 ViewRay Headquarters Ohio Office 815 E. Middlefield Road… | 2017 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K212958 | MRIdian Linac System | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 4, 2021 | Class II | Z-1836-2021 | Software design | Software anomalies affecting the French, German and Italian versions of treatment delivery system (TDS) software. |
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 3 companies; a new generation was cleared every 1.6 years on median.
- 27 of the 41 ancestors have a recall of any class.
- Of its descendants, K212958 (Viewray, Incorporated, 2021) has gone furthest, with 0 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. 2019, 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/K181989 · printed Nov 4, 2026
Cite this page
510(k) Report. “K181989: MRIdian Linac System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K181989
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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