510(k) · Cleared
Recalled · Class II · 2020Viewray 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 May 22, 2012 as substantially equivalent to K092871 (Varian Medical Systems, Inc., 2009) after a 327-day review. Its family tree reaches back 6 generations to 1995. 9 later devices descend from it. It has been recalled 9 times.
- Decided
- May 22, 2012
- Review
- 327 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 9
- Predicates
- 1
Its longest line of descent runs back 6 generations to K926449 (1995). 26 ancestors in all, the oldest K864886 (1987). 9 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK926449 Varian Multileaf Collimator, Release 4.0Varian Assoc., Inc. · 1995
- 5 generations backK973889 Varian Multileaf Collimator with Dynamic Arc Therapy FeatureVarian Medical Systems, Inc. · 1997
- 4 generations backK990085 Millennium MLC -120Varian Assoc., Inc. · 1999 · Recalled
- 3 generations backK050442 Millennium Multi-Leaf CollimatorVarian Medical Systems · 2005 · Recalled
- 2 generations backK071992 High-Definition 120 Multileaf Collimator (HD120 MLC)Varian Medical Systems · 2007 · Recalled
- 1 generation backK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- This deviceK111862 Viewray SystemViewray, Incorporated · 2012
- Descendant · cites it directly · 8 of its ownK162393 The ViewRay (MRIdian) Linac SystemViewray, Incorporated · 2017
- Descendant · 2 generations on · 7 of its ownK170751 MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 2017 · Recalled
- Descendant · 3 generations on · 3 of its ownK182076 Elekta UnityElekta Limited · 2018 · Recalled
- Descendant · 4 generations on · 2 of its ownK192482 Elekta UnityElekta Limited · 2019 · Recalled
- Descendant · 5 generations on · 1 of its ownK212114 Elekta UnityElekta Solutions AB · 2021 · Recalled
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated · 2017 · cites it directly8descendants
- K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 2017 · 2 generations on7descendants
- K182076Elekta UnityElekta Limited · 2018 · 3 generations on3descendants
- K192482Elekta UnityElekta Limited · 2019 · 4 generations on2descendants
- K212114Elekta UnityElekta Solutions AB · 2021 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K926449 | Varian Multileaf Collimator, Release 4.0 | Varian Assoc., Inc. | 1995 | — |
| −5 | K973889 | Varian Multileaf Collimator with Dynamic Arc Therapy Feature | Varian Medical Systems, Inc. | 1997 | — |
| −4 | K990085 | Millennium MLC -120 | Varian Assoc., Inc. | 1999 | 2 |
| −3 | K050442 | Millennium Multi-Leaf Collimator | Varian Medical Systems | 2005 | 2 |
| −2 | K071992 | High-Definition 120 Multileaf Collimator (HD120 MLC) | Varian Medical Systems | 2007 | 4 |
| −1 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| 0 (this device) | K111862 | Viewray System | Viewray, Incorporated | 2012 | — |
| +1 | K162393 | The ViewRay (MRIdian) Linac System | Viewray, Incorporated | 2017 | — |
| +2 | K170751 | MRIdian Linac System with 138-leaf Collimator | Viewray, Incorporated | 2017 | 4 |
| +3 | K182076 | Elekta Unity | Elekta Limited | 2018 | 4 |
| +4 | K192482 | Elekta Unity | Elekta Limited | 2019 | 3 |
| +5 | K212114 | Elekta Unity | Elekta Solutions AB | 2021 | 1 |
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 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K092871 | Trilogy MXSummary page 1…): IWB Common/Usual Name: The ViewRay M System for Radiation Therapy Predicate Device: Trilogy Mx'" Radiotherapy Delivery System K092871, 11/30/2009 Device Description: The ViewRay M System for Radiation Therapy is a single medical device that combines a magnetic… | 2009 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162393 | The ViewRay (MRIdian) Linac System | 2017 | 8 |
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-0481-2021 | 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 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. |
| Mar 7, 2016 | Class II | Z-1309-2016 | Software design | When editing the isocenter or the couch position of the plan while in the treatment workflow (in the Points screen) and re-optimizing, the software will not prompt the user to shift the couch to the new isocenter. As a result there is the… |
| Dec 24, 2015 | Class II | Z-0806-2016 | Software design | The system loaded a completion fraction in the incorrect order after a treatment interruption. |
| Aug 27, 2015 | Class II | Z-0115-2016 | Device Design | ViewRay discovered that in the event that an encoder breaks or fails on the Patient Handling System (PHS, or couch), when attempting to restart the system, the couch could move unexpectedly. |
| May 7, 2015 | Class II | Z-1954-2015 | Software design | The software was failing to determine new patient locations if imaging is not enabled during treatment. |
| Apr 1, 2015 | Class II | Z-2085-2015 | Software Design Change | ViewRay received a report that the couch moved unexpectedly into the bore after performing a RTCS reboot. |
| Jan 15, 2015 | Class II | Z-1580-2015 | Software Design Change | The software was not correctly using the RT (Radiation Therapy) to MR (Magnetic Resonance image) coordinate correction for non HFS (Head First Supine) patient orientations, resulting in slice mismatch error. |
The 5 latest of 9 recalls; the web page lists all.
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 2.5 years on median.
- 19 of the 26 ancestors have a recall of any class.
- Of its descendants, K162393 (Viewray, Incorporated, 2017) has gone furthest, with 8 descendants of its own.
- 2 other devices also cite its predicate K092871.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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 ViewRay 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/K111862 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111862: Viewray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111862
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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