510(k) · Cleared
Recalled · 2010Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · IYE Accelerator, Linear, Medical
Cleared on Feb 9, 2007 as substantially equivalent to K061140 (Varian Medical Systems, 2006) and 1 other predicate after a 30-day review. Its family tree reaches back 3 generations to 1991. 78 later devices descend from it. It has been recalled 5 times.
- Decided
- Feb 9, 2007
- Review
- 30 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 3 generations to K913119 (1991). 5 ancestors in all. 78 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK913119 Varian C-Series Clinacs (Clinac 2300C/D)Varian Assoc., Inc. · 1991 · Recalled
- 2 generations backK033343 Trilogy Radiotherapy Delivery SystemVarian Medical Systems, Inc. · 2003 · Recalled
- 1 generation backK061140 Trilogy Radiotherapy Delivery SystemVarian Medical Systems · 2006
- This deviceK070094 Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc. · 2007
- Descendant · cites it directly · 77 of its ownK072916 Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- Descendant · 4 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012
- Descendant · 4 generations on · 36 of its ownK123808 AgilityElekta, Ltd. · 2013 · Recalled
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- K072916Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · cites it directly77descendants
- K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · 2 generations on61descendants
- K111106TruebeamVarian Medical Systems, Inc. · 2011 · 3 generations on43descendants
- K123291TruebeamVarian Medical Systems, Inc. · 2012 · 4 generations on37descendants
- K123808AgilityElekta, Ltd. · 2013 · 4 generations on36descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K913119 | Varian C-Series Clinacs (Clinac 2300C/D) | Varian Assoc., Inc. | 1991 | 6 |
| −2 | K033343 | Trilogy Radiotherapy Delivery System | Varian Medical Systems, Inc. | 2003 | 3 |
| −1 | K061140 | Trilogy Radiotherapy Delivery System | Varian Medical Systems | 2006 | — |
| 0 (this device) | K070094 | Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System | Varian Medical Systems, Inc. | 2007 | — |
| +1 | K072916 | Trilogy System with Rapidarc | Varian Medical Systems, Inc. | 2007 | 2 |
| +2 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| +3 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| +4 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| +4 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 3 | 0 |
| 2010 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 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 |
|---|---|---|---|
| * | K061140 | Trilogy Radiotherapy Delivery SystemSummary page 1…duct Code: 90 lYE 3. Predicate Devices to claim substantial equivalence: Varian Medical Systems Trilogy Tx Radiotherapy Delivery System - K061140 and Varian Medical Systems Trilogy Radiotherapy Delivery System - K033343 4. Description of the Device:… | 2006 |
| * | K033343 | Trilogy Radiotherapy Delivery SystemSummary page 1…uivalence: Varian Medical Systems Trilogy Tx Radiotherapy Delivery System - K061140 and Varian Medical Systems Trilogy Radiotherapy Delivery System - K033343 4. Description of the Device: The changes to the Trilogy Radiotherapy Delivery System and Trilogy Tx Delivery Sy… | 2003 |
What descends from it? (78)
See all 781 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072916 | Trilogy System with Rapidarc | 2007 | 77 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2010 | Not classified | Z-1249-2011 | Device Design | Position errors may result in misdelivery of radiation. |
| Jun 10, 2010 | Not classified | Z-0886-2011 | Other | The Auto goto or Auto setup functions in C-Series version 7 software ignore the couch angle and exceed motion zone (unless a tolerance is defined by the user); it has the potential for collision with the patient on the couch. |
| Oct 8, 2009 | Not classified | Z-0910-2011 | Nonconforming Material/Component | Product may deliver radiation treatment to areas larger than intended,to healthy tissue. |
| Sep 10, 2007 | Not classified | Z-0545-2008 | Labeling design | The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle. |
| Sep 10, 2007 | Not classified | Z-0544-2008 | Labeling design | Treatment Error: The collimator drive chain may break or slip off of its drive track, allowing the collimator to rotate freely without motor control; if undetected resulting in a treatment with the wrong collimator angle. |
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 2.4 years on median.
- 3 of the 5 ancestors have a recall of any class.
- Of its descendants, K072916 (Varian Medical Systems, Inc., 2007) has gone furthest, with 77 descendants of its own.
- 2 other devices also cite its predicate K061140.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Trilogy Tm 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/K070094 · printed Nov 5, 2026
Cite this page
510(k) Report. “K070094: Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K070094
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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