510(k) · Cleared
Recalled · 2005Acuity Radiation Therapy Simulator
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 Oct 11, 2002 as substantially equivalent to K964138 (Varian Medical Systems, Inc., 1997) after a 28-day review. Its family tree reaches back 2 generations to 1985. 1 later device descends from it. It has been recalled once.
- Decided
- Oct 11, 2002
- Review
- 28 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 2 generations to K853349 (1985). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK853349 Varian Ximatron C-Series Radiotherapy Treatment STVarian Assoc., Inc. · 1985 · Recalled
- 1 generation backK964138 Varian Ximatron C-Series Radiation Therapy Simulator with Version…Varian Medical Systems, Inc. · 1997 · Recalled
- This deviceK023052 Acuity Radiation Therapy SimulatorVarian Medical Systems, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK033339 Acuity with Conebeam Computed TomographyVarian Medical Systems, Inc. · 2003 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K033339Acuity with Conebeam Computed TomographyVarian Medical Systems, Inc. · 2003 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853349 | Varian Ximatron C-Series Radiotherapy Treatment ST | Varian Assoc., Inc. | 1985 | 1 |
| −1 | K964138 | Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software | Varian Medical Systems, Inc. | 1997 | 1 |
| 0 (this device) | K023052 | Acuity Radiation Therapy Simulator | Varian Medical Systems, Inc. | 2002 | — |
| +1 | K033339 | Acuity with Conebeam Computed Tomography | Varian Medical Systems, Inc. | 2003 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K964138 | Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 SoftwareSummary page 2…Page 1 of 3 Predicate Device: Varian Ximatron C-Series Radiation Therapy Simulatory with Version 4.2 Software, K964138. Product Descriution: The Varian Acuity is a Radiation Therapy Simulator. Its main function is to provide the means of plannin… | 1997 |
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 |
|---|---|---|---|
| K033339 | Acuity with Conebeam Computed Tomography | 2003 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 23, 2005 | Not classified | Z-0393-06 | Other | The export of multi-static segment BrainLab M 3 MLC from VARiS Vision may produce undesirable result, which could lead to mistreatment. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
- 2 of the 2 ancestors have a recall of any class.
- Of its descendants, K033339 (Varian Medical Systems, Inc., 2003) has gone furthest, with 0 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 | — |
What is it indicated for?
The Acuity 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 as stated in the FDA summary.
https://510kreport.com/device/K023052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K023052: Acuity Radiation Therapy Simulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023052
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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