510(k) · Cleared
Recalled · 2010Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Medical Systems, Inc. · KPQ System, Simulation, Radiation Therapy
Cleared on Jan 10, 1997 as substantially equivalent to K853349 (Varian Assoc., Inc., 1985) after an 87-day review. Its family tree reaches back 1 generation to 1985. 2 later devices descend from it. It has been recalled once.
- Decided
- Jan 10, 1997
- Review
- 87 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K853349 (1985). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK853349 Varian Ximatron C-Series Radiotherapy Treatment STVarian Assoc., Inc. · 1985 · Recalled
- This deviceK964138 Varian Ximatron C-Series Radiation Therapy Simulator with Version…Varian Medical Systems, Inc. · 1997
- Descendant · cites it directly · 1 of its ownK023052 Acuity Radiation Therapy SimulatorVarian Medical Systems, Inc. · 2002 · Recalled
- Descendant · 2 generations on · 0 of its ownK033339 Acuity with Conebeam Computed TomographyVarian Medical Systems, Inc. · 2003 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K853349 | Varian Ximatron C-Series Radiotherapy Treatment ST | Varian Assoc., Inc. | 1985 | 1 |
| 0 (this device) | K964138 | Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software | Varian Medical Systems, Inc. | 1997 | — |
| +1 | K023052 | Acuity Radiation Therapy Simulator | Varian Medical Systems, Inc. | 2002 | 1 |
| +2 | K033339 | Acuity with Conebeam Computed Tomography | Varian Medical Systems, Inc. | 2003 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 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 KPQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K853349 | Varian Ximatron C-Series Radiotherapy Treatment STSummary page 1…arian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software Varian Ximatron C-Series Radiation Therapy Simulator, cleared October 28, 1985, 510(k) No. K853349 The Varian Ximatron C-Series Radiation Therapy Simulator consists of a stand that supports a gantry and houses various electroni… | 1985 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K023052 | Acuity Radiation Therapy Simulator | 2002 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 19, 2010 | Not classified | Z-0892-2011 | Other | There is a potential for failure of a lead screw drive system or image intensifier lead screw drive assembly, if normal maintenance inspections are not followed correctly. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All KPQ devicesKPQ System, Simulation, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPQ
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · KPQ
Too few KPQ 510(k)s in any year since 2007 to give a median.
Recalls per year · KPQ
1in 2014
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPQ
1in 2020
MAUDE reports naming product code KPQ, 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 | 1 | — | 6 | 17 |
| 2008 | 1 | — | 3 | 12 |
| 2009 | 1 | — | 1 | 7 |
| 2010 | 1 | — | 0 | 10 |
| 2011 | 0 | — | 0 | 12 |
| 2012 | 0 | — | 1 | 11 |
| 2013 | 1 | — | 1 | 1 |
| 2014 | 1 | — | 1 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Ximatron Radiation Therapy Simulator is to be used in radiation therapy simulation, using a fluoroscopic and/or radiographic x-ray system for visualizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field to be applied.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K964138 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964138: Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964138
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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