510(k) · Cleared
Recalled · 20114D Integrated Treatment Console with Patient Accessory Verification System (Pavs)
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 May 9, 2008 as substantially equivalent to K050479 (Varian Medical Systems, 2005) after a 28-day review. Its family tree reaches back 2 generations to 2000. 69 later devices descend from it. It has been recalled 3 times.
- Decided
- May 9, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K001643 (2000). 69 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK001643 Varis 1.4GVarian Medical Systems, Inc. · 2000 · Recalled
- 1 generation backK050479 4D Integrated Treatment ConsoleVarian Medical Systems · 2005 · Recalled
- This deviceK081036 4D Integrated Treatment Console with Patient Accessory Verification…Varian Medical Systems, Inc. · 2008
- Descendant · cites it directly · 61 of its ownK092871 Trilogy MXVarian Medical Systems, Inc. · 2009 · Recalled
- Descendant · 2 generations on · 43 of its ownK111106 TruebeamVarian Medical Systems, Inc. · 2011 · Recalled
- Descendant · 3 generations on · 37 of its ownK123291 TruebeamVarian Medical Systems, Inc. · 2012
- Descendant · 3 generations on · 36 of its ownK123808 AgilityElekta, Ltd. · 2013 · Recalled
- Descendant · 4 generations on · 31 of its ownK140528 True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · Recalled
Showing 5 of 69 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 69 · See all- K092871Trilogy MXVarian Medical Systems, Inc. · 2009 · cites it directly61descendants
- K111106TruebeamVarian Medical Systems, Inc. · 2011 · 2 generations on43descendants
- K123291TruebeamVarian Medical Systems, Inc. · 2012 · 3 generations on37descendants
- K123808AgilityElekta, Ltd. · 2013 · 3 generations on36descendants
- K140528True Beam, True Beam STX, EdgeVarian Medical Systems, Inc. · 2014 · 4 generations on31descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001643 | Varis 1.4G | Varian Medical Systems, Inc. | 2000 | 8 |
| −1 | K050479 | 4D Integrated Treatment Console | Varian Medical Systems | 2005 | 2 |
| 0 (this device) | K081036 | 4D Integrated Treatment Console with Patient Accessory Verification System… | Varian Medical Systems, Inc. | 2008 | — |
| +1 | K092871 | Trilogy MX | Varian Medical Systems, Inc. | 2009 | 5 |
| +2 | K111106 | Truebeam | Varian Medical Systems, Inc. | 2011 | 5 |
| +3 | K123291 | Truebeam | Varian Medical Systems, Inc. | 2012 | — |
| +3 | K123808 | Agility | Elekta, Ltd. | 2013 | 2 |
| +4 | K140528 | True Beam, True Beam STX, Edge | Varian Medical Systems, Inc. | 2014 | 2 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 9 | 0 |
| 2022 | 4 | 0 |
| 2023 | 9 | 0 |
| 2024 | 2 | 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? (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 |
|---|---|---|---|
| * | K050479 | 4D Integrated Treatment ConsoleSummary page 1…le radiation therapy system, 21 CFR 892.5050, IYE, Class II Common/Usual Name: 4DITC Predicate Devices: 4D Integrated Treatment Console, K050479 Device Description: The 4D Integrated Treatment Console (4DITC) has been modified to add a new capabil… | 2005 |
What descends from it? (69)
See all 693 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 |
|---|---|---|---|---|
| Jun 27, 2011 | Not classified | Z-3100-2011 | Software design | In certain configurations, the 4DITC can interpret a RapidArc or VMAT treatment field as 3D Conformal Arc Treatment Plan. If a RapidArc or VMAT treatment field is incorrectly interpreted as Conformal Arc, the field will be delivered with… |
| Jun 23, 2011 | Not classified | Z-3098-2011 | Software design | Varian has scheduled for an upgrade of the device from current version to 10.2. There are circumstances in which the 4DITC may be involved in a failure to correctly record treatment history information. |
| Dec 14, 2010 | Not classified | Z-0932-2011 | Software design | Multiple isocenter plans will load on the 4DITC and are available for imaging and treatment, but the 4DITC software does not recognize that mulitplex isocenter is present. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K092871 (Varian Medical Systems, Inc., 2009) has gone furthest, with 61 descendants of its own.
- 2 other devices also cite its predicate K050479.
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 4DITC function is designed to assist the operator of a radiation therapy device in
providing accurate treatment setups for each patient by monitoring setup parameters and
preventing the radiation therapy device from commencing irradiation when any
parameter is out of conformance with the treatment plan.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081036 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081036: 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081036
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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