510(k) · Cleared
ClearedTrilogy Radiotherapy Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems · IYE Accelerator, Linear, Medical
Cleared on May 15, 2006 as substantially equivalent to K033343 (Varian Medical Systems, Inc., 2003) and 1 other predicate after a 21-day review. Its family tree reaches back 2 generations to 1991. 86 later devices descend from it.
- Decided
- May 15, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K913119 (1991). 4 ancestors in all. 86 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK913119 Varian C-Series Clinacs (Clinac 2300C/D)Varian Assoc., Inc. · 1991 · Recalled
- 1 generation backK033343 Trilogy Radiotherapy Delivery SystemVarian Medical Systems, Inc. · 2003 · Recalled
- This deviceK061140 Trilogy Radiotherapy Delivery SystemVarian Medical Systems · 2006
- Descendant · cites it directly · 78 of its ownK070094 Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 77 of its ownK072916 Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 3 generations on · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 4 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- Descendant · 5 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012
Showing 5 of 86 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 86 · See all- K070094Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc. · 2007 · cites it directly78descendants
- K072916Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · 2 generations on77descendants
- K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · 3 generations on61descendants
- K111106TruebeamVarian Medical Systems, Inc. · 2011 · 4 generations on43descendants
- K123291TruebeamVarian Medical Systems, Inc. · 2012 · 5 generations on37descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K913119 | Varian C-Series Clinacs (Clinac 2300C/D) | Varian Assoc., Inc. | 1991 | 6 |
| −1 | K033343 | Trilogy Radiotherapy Delivery System | Varian Medical Systems, Inc. | 2003 | 3 |
| 0 (this device) | K061140 | Trilogy Radiotherapy Delivery System | Varian Medical Systems | 2006 | — |
| +1 | K070094 | Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System | Varian Medical Systems, Inc. | 2007 | 5 |
| +2 | K072916 | Trilogy System with Rapidarc | Varian Medical Systems, Inc. | 2007 | 2 |
| +3 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| +4 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| +5 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 3 | 0 |
| 2017 | 7 | 0 |
| 2018 | 7 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 7 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K033343 | Trilogy Radiotherapy Delivery SystemSummary page 1…Product Code: 90 lYE 3. Predicate Devices to claim substantial equivalence: a. Varian Medical Systems'Trilogy Radiotherapy Delivery System -K033343 b. Accuray's CyberKnife - K041315 4. Description of the Device: The Trilogy Tm Radiotherapy Delivery System, K0333… | 2003 |
| * | K041315 | Cyberknife System for Stereotactic Radiosurgery/RadiotherapySummary page 1…redicate Devices to claim substantial equivalence: a. Varian Medical Systems'Trilogy Radiotherapy Delivery System -K033343 b. Accuray's CyberKnife - K041315 4. Description of the Device: The Trilogy Tm Radiotherapy Delivery System, K033343, is a dual-energy, high dose rate me… | 2004 |
What descends from it? (86)
See all 863 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)
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 15 years and passes through 3 companies; a new generation was cleared every 12.1 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K070094 (Varian Medical Systems, Inc., 2007) has gone furthest, with 78 descendants of its own.
- 1 other device also cites its predicate K033343.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 Trilogy TM Radiotherapy Delivery System and Trilogy Tx Delivery System are indicated for stereotactic 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/K061140 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061140: Trilogy Radiotherapy 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/K061140
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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