510(k) · Cleared
Recalled · Class II · 20144D Integrated Treatment Console
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jan 27, 2014 as substantially equivalent to K091132 (Varian Medical Systems, 2009) after a 90-day review. Its family tree reaches back 4 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Jan 27, 2014
- Review
- 90 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 4 generations to K001643 (2000). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK001643 Varis 1.4GVarian Medical Systems, Inc. · 2000 · Recalled
- 3 generations backK050479 4D Integrated Treatment ConsoleVarian Medical Systems · 2005 · Recalled
- 2 generations backK081036 4D Integrated Treatment Console with Patient Accessory Verification…Varian Medical Systems, Inc. · 2008 · Recalled
- 1 generation backK091132 4D Integrated Treatment ConsoleVarian Medical Systems · 2009 · Recalled
- This deviceK133331 4D Integrated Treatment ConsoleVarian Medical Systems, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK203766 4D Integrated Treatment ConsoleVarian Medical Systems, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K2037664D Integrated Treatment ConsoleVarian Medical Systems, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K001643 | Varis 1.4G | Varian Medical Systems, Inc. | 2000 | 8 |
| −3 | K050479 | 4D Integrated Treatment Console | Varian Medical Systems | 2005 | 2 |
| −2 | K081036 | 4D Integrated Treatment Console with Patient Accessory Verification System… | Varian Medical Systems, Inc. | 2008 | 3 |
| −1 | K091132 | 4D Integrated Treatment Console | Varian Medical Systems | 2009 | 5 |
| 0 (this device) | K133331 | 4D Integrated Treatment Console | Varian Medical Systems, Inc. | 2014 | — |
| +1 | K203766 | 4D Integrated Treatment Console | Varian Medical Systems, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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 MUJ? 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 MUJ device
- #1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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 |
|---|---|---|---|
| * | K091132 | 4D Integrated Treatment ConsoleSummary page 1…Class 11,Product Code MUJ Predicate Device: Varian Medical Systems, Inc., 4D Integrated Treatment Console (k091 132) Device Description: The 40 Integrated Treatment Console (4DITC) allows the user to retrieve tr… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203766 | 4D Integrated Treatment Console | 2021 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 18, 2014 | Class II | Z-2654-2014 | Software design | Due to user error, the 4DITC can improperly allow users to clear a safety interlock imposed by the 4DITC on behalf of Varian's Bar Code Conical Verification system from the BrainLab's ExacTract console when it is used with BCCV. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 4 ancestors have a recall of any class.
- Of its descendants, K203766 (Varian Medical Systems, Inc., 2021) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K091132.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 2025
MAUDE reports naming product code MUJ, 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 | 4 | 67 | 4 | 24 |
| 2008 | 9 | 63 | 10 | 51 |
| 2009 | 16 | 84 | 11 | 24 |
| 2010 | 11 | 56 | 23 | 78 |
| 2011 | 9 | 103 | 17 | 73 |
| 2012 | 8 | 59 | 4 | 39 |
| 2013 | 5 | 64 | 6 | 33 |
| 2014 | 9 | 108 | 2 | 35 |
| 2015 | 13 | 78 | 7 | 30 |
| 2016 | 5 | 80 | 13 | 27 |
| 2017 | 7 | 30 | 4 | 16 |
| 2018 | 7 | 53 | 3 | 25 |
| 2019 | 9 | 56 | 4 | 25 |
| 2020 | 9 | 104 | 2 | 26 |
| 2021 | 11 | 87 | 4 | 15 |
| 2022 | 8 | 168 | 3 | 22 |
| 2023 | 10 | 140 | 2 | 76 |
| 2024 | 9 | 122 | 0 | 9 |
| 2025 | 10 | 186 | 0 | 21 |
| 2026 | 9 | 233 | 2 | — |
What is it indicated for?
The 4D Integrated Treatment Console provides assistance for accurate treatment delivery for each patient by monitoring linear accelerator parameters and by 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/K133331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133331: 4D Integrated Treatment Console.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133331
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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