510(k) · Cleared
Recalled · 20114D Integrated Treatment Console
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 Jun 17, 2009 as substantially equivalent to K050479 (Varian Medical Systems, 2005) and 1 other predicate after a 58-day review. Its family tree reaches back 3 generations to 2000. 5 later devices descend from it. It has been recalled 5 times.
- Decided
- Jun 17, 2009
- Review
- 58 days
- Class
- Class II
- Product code
- IYE
- Recalls
- 5
- Predicates
- 2
Its longest line of descent runs back 3 generations to K001643 (2000). 5 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK001643 Varis 1.4GVarian Medical Systems, Inc. · 2000 · Recalled
- 2 generations backK050479 4D Integrated Treatment ConsoleVarian Medical Systems · 2005 · Recalled
- 1 generation backK081036 4D Integrated Treatment Console with Patient Accessory Verification…Varian Medical Systems, Inc. · 2008 · Recalled
- This deviceK091132 4D Integrated Treatment ConsoleVarian Medical Systems · 2009
- Descendant · cites it directly · 1 of its ownK133331 4D Integrated Treatment ConsoleVarian Medical Systems, Inc. · 2014 · Recalled
- Descendant · cites it directly · 1 of its ownK122616 Panther Ois/R & V Model Version 2.0Prowess, Inc. · 2012
- Descendant · 2 generations on · 0 of its ownK211760 Panther OISProwess, Inc. · 2021
- Descendant · 2 generations on · 0 of its ownK203766 4D Integrated Treatment ConsoleVarian Medical Systems, Inc. · 2021
- Descendant · cites it directly · 0 of its ownK142268 Varian Verification System (VVS)Varian Medical Systems, Inc. · 2014
Most influential descendants
Showing 5 of 5 · See all- K1333314D Integrated Treatment ConsoleVarian Medical Systems, Inc. · 2014 · cites it directly1descendant
- K122616Panther Ois/R & V Model Version 2.0Prowess, Inc. · 2012 · cites it directly1descendant
- K211760Panther OISProwess, Inc. · 2021 · 2 generations on0descendants
- K2037664D Integrated Treatment ConsoleVarian Medical Systems, Inc. · 2021 · 2 generations on0descendants
- K142268Varian Verification System (VVS)Varian Medical Systems, Inc. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001643 | Varis 1.4G | Varian Medical Systems, Inc. | 2000 | 8 |
| −2 | K050479 | 4D Integrated Treatment Console | Varian Medical Systems | 2005 | 2 |
| −1 | K081036 | 4D Integrated Treatment Console with Patient Accessory Verification System… | Varian Medical Systems, Inc. | 2008 | 3 |
| 0 (this device) | K091132 | 4D Integrated Treatment Console | Varian Medical Systems | 2009 | — |
| +1 | K133331 | 4D Integrated Treatment Console | Varian Medical Systems, Inc. | 2014 | 1 |
| +1 | K122616 | Panther Ois/R & V Model Version 2.0 | Prowess, Inc. | 2012 | — |
| +2 | K211760 | Panther OIS | Prowess, Inc. | 2021 | — |
| +2 | K203766 | 4D Integrated Treatment Console | Varian Medical Systems, Inc. | 2021 | — |
| +1 | K142268 | Varian Verification System (VVS) | Varian Medical Systems, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2014 | 2 | 0 |
| 2021 | 2 | 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 |
|---|---|---|---|
| * | K050479 | 4D Integrated Treatment ConsoleSummary page 1…Class II Product Code: MUJ Common/Usual Name: 4DITC Predicate Devices: 4D Integrated Treatment Console, K050479 4D Integrated Treatment Console with PAVS, K081036 Device Description: The 4D In… | 2005 |
| * | K081036 | 4D Integrated Treatment Console with Patient Accessory Verification System (Pavs)Summary page 1…4DITC Predicate Devices: 4D Integrated Treatment Console, K050479 4D Integrated Treatment Console with PAVS, K081036 Device Description: The 4D Integrated Console provides the user with: a… | 2008 |
What descends from it? (5)
3 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 |
|---|---|---|---|---|
| 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… |
| Dec 12, 2011 | Not classified | Z-0715-2012 | Device Design | When multiple conical collimator treatment plans are scheduled to be treated in a session, the Plan Label should be displayed on the BCCV dialog box should match the Plan Label on the 4DITC. However, the name of the plan is not being… |
| Jul 21, 2011 | Not classified | Z-3194-2011 | Pending | The 4D Integrated Treatment Console may erratically fail to load the planned physical wedge accessory without warning or notification when receiving an approved plan from the oncology information system. |
| Feb 28, 2011 | Not classified | Z-2119-2011 | Software design | A software anomaly, in that the Multileaf Collimator (MLC) message displayed on the 4DITC on versions 8.6 and below, does NOT interlock beam delivery. |
| Oct 16, 2009 | Not classified | Z-0891-2011 | Device Design | Software anomaly may result in a design deficiency causing Plan Edit Settings to malfunction under specific circumstances, where the user selects to use a Cone Beam CT set up field. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 2 companies; a new generation was cleared every 3.1 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K133331 (Varian Medical Systems, Inc., 2014) has gone furthest, with 1 descendant 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. 2009, 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/K091132 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091132: 4D Integrated Treatment Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091132
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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