510(k) · Cleared
Recalled · Class II · 2021Viewray Treatment Planning and Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Viewray, Incorporated · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jan 12, 2011 as substantially equivalent to K092871 (Varian Medical Systems, Inc., 2009) and 1 other predicate after a 103-day review. Its family tree reaches back 7 generations to 2001. 15 later devices descend from it. It has been recalled once.
- Decided
- Jan 12, 2011
- Review
- 103 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 7 generations to K010975 (2001). 37 ancestors in all, the oldest K864886 (1987). 15 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK010975 Eclipse 6.5Varian Medical Systems, Inc. · 2001 · Recalled
- 6 generations backK030981 EclipseVarian Medical Systems, Inc. · 2003
- 5 generations backK041403 Eclipse with AaaVarian Medical Systems · 2004
- 4 generations backK050296 Eclipse Treatment Planning SystemVarian Medical Systems · 2005
- 3 generations backK071873 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 2 generations backK073020 Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK091492 Modification to Eclipse Treatment Planning SystemVarian Medical Systems, Inc. · 2009 · Recalled
- This deviceK102915 Viewray Treatment Planning and Delivery SystemViewray, Incorporated · 2011
- 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 · cites it directly · 5 of its ownK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- Descendant · 2 generations on · 4 of its ownK190178 Monaco RTP SystemElekta, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 3 of its ownK202789 Monaco Rtp SystemElekta Solutions AB · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K162393The ViewRay (MRIdian) Linac SystemViewray, Incorporated · 2017 · cites it directly8descendants
- K170751MRIdian Linac System with 138-leaf CollimatorViewray, Incorporated · 2017 · 2 generations on7descendants
- K183037Monaco RTP SystemElekta, Inc. · 2018 · cites it directly5descendants
- K190178Monaco RTP SystemElekta, Inc. · 2019 · 2 generations on4descendants
- K202789Monaco Rtp SystemElekta Solutions AB · 2021 · 3 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K010975 | Eclipse 6.5 | Varian Medical Systems, Inc. | 2001 | 3 |
| −6 | K030981 | Eclipse | Varian Medical Systems, Inc. | 2003 | — |
| −5 | K041403 | Eclipse with Aaa | Varian Medical Systems | 2004 | — |
| −4 | K050296 | Eclipse Treatment Planning System | Varian Medical Systems | 2005 | — |
| −3 | K071873 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 5 |
| −2 | K073020 | Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2007 | 6 |
| −1 | K091492 | Modification to Eclipse Treatment Planning System | Varian Medical Systems, Inc. | 2009 | 2 |
| 0 (this device) | K102915 | Viewray Treatment Planning and Delivery System | Viewray, Incorporated | 2011 | — |
| +1 | K162393 | The ViewRay (MRIdian) Linac System | Viewray, Incorporated | 2017 | — |
| +2 | K170751 | MRIdian Linac System with 138-leaf Collimator | Viewray, Incorporated | 2017 | 4 |
| +1 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
| +2 | K190178 | Monaco RTP System | Elekta, Inc. | 2019 | 5 |
| +3 | K202789 | Monaco Rtp System | Elekta Solutions AB | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2026 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 |
|---|---|---|---|
| * | K092871 | Trilogy MXSummary page 1…tion name: Radionuclide Radiation System (21CFR 892.5750, Product Code IWB) Predicate Device: Varian Medical Systems' Trilogy Mx TM System K(092871 andEclipseM" Treatment Planning System K(091492 Description: The ViewRay M Treatment Planning and De… | 2009 |
| * | K091492 | Modification to Eclipse Treatment Planning SystemSummary page 1…uct Code IWB) Predicate Device: Varian Medical Systems' Trilogy Mx TM System K(092871 andEclipseM" Treatment Planning System K(091492 Description: The ViewRay M Treatment Planning and Delivery System (TPDS) provides tools for planning… | 2009 |
What descends from it? (15)
See all 152 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 |
|---|---|---|---|---|
| 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 24 of the 37 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 MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
Use of the ViewRaynM Treatment Planning and Delivery System is indicated for stereoitactic radiosurgery and precision radiotherapy for lesions, tumors, and conditions anywhere in the body when radiation treatment is indicated.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102915 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102915: Viewray Treatment Planning and Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102915
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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