510(k) · Cleared
Recalled · 2010Acuity with Conebeam Computed Tomography
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 Dec 30, 2003 as substantially equivalent to K023052 (Varian Medical Systems, Inc., 2002) and 1 other predicate after a 74-day review. Its family tree reaches back 3 generations to 1985. It has been recalled 3 times.
- Decided
- Dec 30, 2003
- Review
- 74 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 3 generations to K853349 (1985). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK853349 Varian Ximatron C-Series Radiotherapy Treatment STVarian Assoc., Inc. · 1985 · Recalled
- 2 generations backK964138 Varian Ximatron C-Series Radiation Therapy Simulator with Version…Varian Medical Systems, Inc. · 1997 · Recalled
- 1 generation backK023052 Acuity Radiation Therapy SimulatorVarian Medical Systems, Inc. · 2002 · Recalled
- This deviceK033339 Acuity with Conebeam Computed TomographyVarian Medical Systems, Inc. · 2003
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K853349 | Varian Ximatron C-Series Radiotherapy Treatment ST | Varian Assoc., Inc. | 1985 | 1 |
| −2 | K964138 | Varian Ximatron C-Series Radiation Therapy Simulator with Version 4.2 Software | Varian Medical Systems, Inc. | 1997 | 1 |
| −1 | K023052 | Acuity Radiation Therapy Simulator | Varian Medical Systems, Inc. | 2002 | 1 |
| 0 (this device) | K033339 | Acuity with Conebeam Computed Tomography | Varian Medical Systems, Inc. | 2003 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1998 | 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? (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 |
|---|---|---|---|
| * | K023052 | Acuity Radiation Therapy SimulatorSummary page 1…Class II Product Code: KPR 3. Predicate Devices to claim substantial equivalence: a. Acuity Radiation Therapy Simulator, K023052 b. Ximatron Scanvision, K981056 4. Description of the Device: Acuity with ConeBeam Computed Tomography (CBCT)… | 2002 |
| * | K981056 | Varian Ximatron Scan Vision CTSummary page 1…Product Code: KPR 3. Predicate Devices to claim substantial equivalence: a. Acuity Radiation Therapy Simulator, K023052 b. Ximatron Scanvision, K981056 4. Description of the Device: Acuity with ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncol… | 1998 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 19, 2010 | Not classified | Z-1003-2011 | Labeling mix-ups | The product has been shipped since 2005 with the wrong label regarding max weight to be used on accessory rails. |
| Aug 11, 2008 | Not classified | Z-0117-2009 | Device Design | During couch movement, a patient's fingers may get pinched at certain points which could result in broken, disengaged or pinched fingers. |
| Jan 3, 2008 | Not classified | Z-1460-2008 | Software design | Incorrect Image Orientation: The image orientation tag may not be set correctly if the patient has been scanned with an orientation other than Head First Spine. When such images are imported to a treatment planning system, they may appear… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 2 companies; a new generation was cleared every 5.7 years on median.
- 3 of the 5 ancestors have a recall of any class.
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 irridation field to be applied. The Acuity ConeBeam Computed Tomography (CBCT) is intended to assist the Radiation Oncologist in acquiring 3D "multislice" planning data in patient set-ups for the purpose of radiation therapy treatment planning and patient positioning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033339 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033339: Acuity with Conebeam Computed Tomography.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033339
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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