510(k) · Cleared
Recalled · 2012Truebeam
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 Aug 18, 2011 as substantially equivalent to K092871 (Varian Medical Systems, Inc., 2009) after a 120-day review. Its family tree reaches back 6 generations to 1995. 43 later devices descend from it. It has been recalled 5 times.
- Decided
- Aug 18, 2011
- Review
- 120 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 6 generations to K926449 (1995). 26 ancestors in all, the oldest K864886 (1987). 43 later devices descend from it, 2 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 deviceK111106 TruebeamVarian Medical Systems, Inc. · 2011
- Descendant · cites it directly · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012
- Descendant · cites it directly · 36 of its ownK123808 AgilityElekta, Ltd. · 2013 · Recalled
- Descendant · 2 generations on · 31 of its ownK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 25 of its ownK143224 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · 4 generations on · 23 of its ownK162472 TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K123291TruebeamVarian Medical Systems, Inc. · 2012 · cites it directly37descendants
- K123808AgilityElekta, Ltd. · 2013 · cites it directly36descendants
- K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · 2 generations on31descendants
- K143224TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2014 · 3 generations on25descendants
- K162472TrueBeam-TrueBeam STx-EdgeVarian Medical Systems, Inc. · 2017 · 4 generations on23descendants
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) | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | — |
| +1 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| +1 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
| +2 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
| +3 | K143224 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2014 | 1 |
| +4 | K162472 | TrueBeam-TrueBeam STx-Edge | Varian Medical Systems, Inc. | 2017 | — |
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 |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 4 | 0 |
| 2022 | 2 | 0 |
| 2023 | 7 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 4 | 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…Product Code: 90 lYE Common/Usual Name: TrueBeam Radiotherapy Delivery System Predicate Device: Trilogy Mx Radiotherapy System and Accessories: K092871 Device Description: The TrueBea mTM Radiotherapy Delivery System is a medical linear accelerator… | 2009 |
What descends from it? (43)
See all 432 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 |
|---|---|---|---|---|
| Apr 9, 2012 | Not classified | Z-1495-2012 | Device Design | A software anomaly has been identified in TrueBeam when using respiratory gating with patients in the prone position. The gating curve is inverted when a prone patient plan is loaded into TrueBeam. |
| Apr 9, 2012 | Not classified | Z-1617-2012 | Labeling design | Varian received a report involving a Gantry collision and is sending a notification to remind users of the collision protection tools available with TrueBeam and TrueBeam STx, including actions the operator should be aware of. |
| Jan 30, 2012 | Not classified | Z-1175-2012 | Device Design | An anomaly has been identified with the respiratory gating software of TrueBeam. When importing breath-hold gating protocols, the gating thresholds can be reset to default values, rather than retaining the thresholds established during… |
| Dec 12, 2011 | Not classified | Z-0691-2012 | Device Design | Varian has discovered that on 4D Integrated Treatment Console and TrueBeam, the ad-hoc CIAO(Complete Irradiated Area Outline) calculation results in the CIAO generation that is different from the CIAO in RT Chart. The 4DITC algorithm adds… |
| Oct 31, 2011 | Not classified | Z-0364-2012 | Device Design | An anomaly has been identified with the TrueBeam and TrueBeam STx systems where, under certain tuning conditions, the electron beam emerging from the bend magnet may have an elongated spot shape. |
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.
- 19 of the 26 ancestors have a recall of any class.
- Of its descendants, K123291 (Varian Medical Systems, Inc., 2012) has gone furthest, with 37 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. 2011, 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?
TrueBeam 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/K111106 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111106: Truebeam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111106
Report an extraction error
Are you the manufacturer?
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