510(k) · Cleared
Recalled · Class II · 2012Trilogy with External System Gating Interface
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 Jul 14, 2008 as substantially equivalent to K072916 (Varian Medical Systems, Inc., 2007) after a 77-day review. Its family tree reaches back 5 generations to 1991. 6 later devices descend from it. It has been recalled once.
- Decided
- Jul 14, 2008
- Review
- 77 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K913119 (1991). 7 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK913119 Varian C-Series Clinacs (Clinac 2300C/D)Varian Assoc., Inc. · 1991 · Recalled
- 4 generations backK033343 Trilogy Radiotherapy Delivery SystemVarian Medical Systems, Inc. · 2003 · Recalled
- 3 generations backK061140 Trilogy Radiotherapy Delivery SystemVarian Medical Systems · 2006
- 2 generations backK070094 Trilogy Radiotherapy Delivery System and Trilogy TX Delivery SystemVarian Medical Systems, Inc. · 2007 · Recalled
- 1 generation backK072916 Trilogy System with RapidarcVarian Medical Systems, Inc. · 2007 · Recalled
- This deviceK081188 Trilogy with External System Gating InterfaceVarian Medical Systems, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK100890 Varian High Energy Linear AcceleratorVarian Medical Systems · 2010 · Recalled
- Descendant · 2 generations on · 3 of its ownK112839 Varian High Energy Linear AcceleratorVarian Medical Systems · 2011 · Recalled
- Descendant · 3 generations on · 2 of its ownK131807 High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2013 · Recalled
- Descendant · 4 generations on · 1 of its ownK162476 Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2016
- Descendant · 5 generations on · 0 of its ownK181404 Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf…Varian Medical Systems, Inc. · 2018 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K100890Varian High Energy Linear AcceleratorVarian Medical Systems · 2010 · cites it directly4descendants
- K112839Varian High Energy Linear AcceleratorVarian Medical Systems · 2011 · 2 generations on3descendants
- K131807High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2013 · 3 generations on2descendants
- K162476Varian High Energy Linear AcceleratorVarian Medical Systems, Inc. · 2016 · 4 generations on1descendant
- K181404Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf CollimatorVarian Medical Systems, Inc. · 2018 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K913119 | Varian C-Series Clinacs (Clinac 2300C/D) | Varian Assoc., Inc. | 1991 | 6 |
| −4 | K033343 | Trilogy Radiotherapy Delivery System | Varian Medical Systems, Inc. | 2003 | 3 |
| −3 | K061140 | Trilogy Radiotherapy Delivery System | Varian Medical Systems | 2006 | — |
| −2 | K070094 | Trilogy Radiotherapy Delivery System and Trilogy TX Delivery System | Varian Medical Systems, Inc. | 2007 | 5 |
| −1 | K072916 | Trilogy System with Rapidarc | Varian Medical Systems, Inc. | 2007 | 2 |
| 0 (this device) | K081188 | Trilogy with External System Gating Interface | Varian Medical Systems, Inc. | 2008 | — |
| +1 | K100890 | Varian High Energy Linear Accelerator | Varian Medical Systems | 2010 | 11 |
| +2 | K112839 | Varian High Energy Linear Accelerator | Varian Medical Systems | 2011 | 1 |
| +3 | K131807 | High Energy Linear Accelerator | Varian Medical Systems, Inc. | 2013 | 2 |
| +4 | K162476 | Varian High Energy Linear Accelerator | Varian Medical Systems, Inc. | 2016 | — |
| +5 | K181404 | Varian High Energy Linear Accelerator, UNIQUE, Varian Multileaf Collimator | Varian Medical Systems, Inc. | 2018 | 1 |
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 |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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 |
|---|---|---|---|
| * | K072916 | Trilogy System with RapidarcSummary page 1…Class II Product Code: 90 IYE/' 3. Predicate Device to claim substantial equivalence: Varian Trilogy Tx Radiotherapy System -K072916 4. Description of the Device: The Trilogy System modifications enable the export of beam information to external… | 2007 |
What descends from it? (6)
2 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 |
|---|---|---|---|---|
| Aug 14, 2012 | Class II | Z-2383-2012 | Nonconforming Material/Component | Some X-jaw (lower collimator jaw) carriers were made using the incorrect metal alloy, which can cause the jaw carrier to crack. If both carriers on the same X-jaw crack, the jaw would be able to move freely in the closed direction. The… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 9 months on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K100890 (Varian Medical Systems, 2010) has gone furthest, with 4 descendants of its own.
- 5 other devices also cite its predicate K072916.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Radiotherapy Delivery System is indicated for stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.
The External System Gating Interface is indicated for use in exporting beam information to external gating devices.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081188: Trilogy with External System Gating Interface.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081188
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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