510(k) · Cleared
ClearedSimulix-Evolution with Oncentra Conebeam
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nucletron Corporation · KPQ System, Simulation, Radiation Therapy
Cleared on Oct 24, 2005 as substantially equivalent to K033470 (Nucletron Corporation, 2004) and 1 other predicate after a 56-day review. Its family tree reaches back 2 generations to 1995.
- Decided
- Oct 24, 2005
- Review
- 56 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K946128 (1995). 3 ancestors in all, the oldest K932848 (1994). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K946128 | Simulix-HP | Oldelft Corp. of America | 1995 | — |
| −1 | K033470 | Simulix Evolution | Nucletron Corporation | 2004 | — |
| 0 (this device) | K052361 | Simulix-Evolution with Oncentra Conebeam | Nucletron Corporation | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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 |
|---|---|---|---|
| * | K033470 | Simulix EvolutionSummary page 1…table below: Manufacturer ~~Device 50k1 Nucletron BV FSimulix Evolution K033470 Description: Oncentra ConeBeam is an extension to the Nucletron Simulix Evolution system. The Simulix Evolution is a Radiation… | 2004 |
| * | K932848 | Simulix-MC CT ExtensionSummary page 2…considerations: Simulix Evolution is substantially equivalent to the cleared predicate devices, Simulix Evolution, 510(k)#: K033470 and Simulix-MC CT Extension 510(k)# K932848. Na7i : Frits van Kriekn Date Title: Business Director Nu… | 1994 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 10 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- None of the 3 ancestors has a recall.
- 1 other device also cites its predicate K033470.
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?
Simulix Evolution is a radiation therapy simulation system intended to prepare patients for radiation therapy.
The Simulator emulates the geometrical positions of radiation therapy treatment machines. Using conventional radiographic and fluorographic system, patients are positioned, filmed and marked to prepare them for treatment.
The Oncentra Cone Beam CT option for the Simulix Evolution Radiation Therapy Simulator is intended to assist the Radiation Oncologist in acquiring 3D "multi slice" 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/K052361 · printed Nov 6, 2026
Cite this page
510(k) Report. “K052361: Simulix-Evolution with Oncentra Conebeam.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052361
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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