510(k) · Cleared
Recalled · 2010Varian Ximatron C-Series Radiotherapy Treatment ST
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Assoc., Inc. · KPQ System, Simulation, Radiation Therapy
Cleared on Oct 28, 1985 after a 77-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- Oct 28, 1985
- Review
- 77 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK853349 Varian Ximatron C-Series Radiotherapy Treatment STVarian Assoc., Inc. · 1985
- Descendant · cites it directly · 2 of its ownK964138 Varian Ximatron C-Series Radiation Therapy Simulator with Version…Varian Medical Systems, Inc. · 1997 · Recalled
- Descendant · 2 generations on · 1 of its ownK023052 Acuity Radiation Therapy SimulatorVarian Medical Systems, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 0 of its ownK033339 Acuity with Conebeam Computed TomographyVarian Medical Systems, Inc. · 2003 · Recalled
- Descendant · cites it directly · 0 of its ownK953233 Simview 3000 CT OptionSiemens Medical Solutions USA, Inc. · 1996 · Recalled
Most influential descendants
Showing 4 of 4 · See all- K964138Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 SoftwareVarian Medical Systems, Inc. · 1997 · cites it directly2descendants
- K023052Acuity Radiation Therapy SimulatorVarian Medical Systems, Inc. · 2002 · 2 generations on1descendant
- K033339Acuity with Conebeam Computed TomographyVarian Medical Systems, Inc. · 2003 · 3 generations on0descendants
- K953233Simview 3000 CT OptionSiemens Medical Solutions USA, Inc. · 1996 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K853349 | Varian Ximatron C-Series Radiotherapy Treatment ST | Varian Assoc., Inc. | 1985 | — |
| +1 | K964138 | Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software | Varian Medical Systems, Inc. | 1997 | 1 |
| +2 | K023052 | Acuity Radiation Therapy Simulator | Varian Medical Systems, Inc. | 2002 | 1 |
| +3 | K033339 | Acuity with Conebeam Computed Tomography | Varian Medical Systems, Inc. | 2003 | 3 |
| +1 | K953233 | Simview 3000 CT Option | Siemens Medical Solutions USA, Inc. | 1996 | 4 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
2 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 |
|---|---|---|---|---|
| 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?
- Of its descendants, K964138 (Varian Medical Systems, Inc., 1997) has gone furthest, with 2 descendants of its own.
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 | — |
https://510kreport.com/device/K853349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K853349: Varian Ximatron C-Series Radiotherapy Treatment ST.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K853349
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026