510(k) · Cleared
ClearedQwiksim Virtual Simulation System; Version 2.00
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Impac Medical Systems, Inc. · KPQ System, Simulation, Radiation Therapy
Cleared on Nov 7, 2001 as substantially equivalent to K951830 (General Electric Co., 1995) and 2 other predicates after a 15-day review. Its family tree reaches back 1 generation to 1992. 1 of the 311 devices in its family, counting itself, has a Class I recall. 307 later devices descend from it.
- Decided
- Nov 7, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K923851 (1992). 3 ancestors in all. 307 later devices descend from it, 2 citing it directly. 1 of the 311 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK923851 Acqsim Simulator/LocalizerPhilips Medical Systems (Cleveland), Inc. · 1992
- This deviceK013531 Qwiksim Virtual Simulation System; Version 2.00Impac Medical Systems, Inc. · 2001
- Descendant · cites it directly · 299 of its ownK061006 IkoengeloIkoetech, LLC · 2006
- Descendant · 2 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · 2 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 3 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 3 generations on · 79 of its ownK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
Showing 5 of 307 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…8 generations on · 2025
Most influential descendants
Showing 5 of 307 · See all- K061006IkoengeloIkoetech, LLC · 2006 · cites it directly299descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 2 generations on287descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on201descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 3 generations on200descendants
- K103576Mim 5.2 (Brachy)Mim Software, Inc. · 2011 · 3 generations on79descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K923851 | Acqsim Simulator/Localizer | Philips Medical Systems (Cleveland), Inc. | 1992 | — |
| 0 (this device) | K013531 | Qwiksim Virtual Simulation System; Version 2.00 | Impac Medical Systems, Inc. | 2001 | — |
| +1 | K061006 | Ikoengelo | Ikoetech, LLC | 2006 | — |
| +2 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +2 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +3 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +3 | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 6 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 9 | 0 |
| 2015 | 8 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 22 | 0 |
| 2019 | 20 | 0 |
| 2020 | 25 | 0 |
| 2021 | 23 | 0 |
| 2022 | 28 | 0 |
| 2023 | 25 | 0 |
| 2024 | 27 | 0 |
| 2025 | 34 | 1 |
| 2026 | 33 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K951830 | Advantage SimSummary page 1…ntially equivalent to these products in intended use and safety and effectiveness. 1. Advantage Sim Manufacturer ~ General Electric Co. Previous Premarket Notification # K951830 Previous Submission Date 04/20/95 2. ACQSIM Simulator/Localizer Manufacturer Marconi Medical Systems Previous Pr… | 1995 |
| * | K923851 | Acqsim Simulator/LocalizerSummary page 2…ication # K951830 Previous Submission Date 04/20/95 2. ACQSIM Simulator/Localizer Manufacturer Marconi Medical Systems Previous Premarket Notification # K923851 Previous Submission Date 07/31/92 3. Somavision Manufacturer Varian Assoc., Inc. Previous Premarket Notification # K992751 Pr… | 1992 |
| * | K992751 | SomavisionSummary page 2…l Systems Previous Premarket Notification # K923851 Previous Submission Date 07/31/92 3. Somavision Manufacturer Varian Assoc., Inc. Previous Premarket Notification # K992751 Previous Submission Date 08/16/99 QwikSIM Intended Use QwikSIM is a radiation therapy virtual simulation system for patient im… | 2000 |
What descends from it? (307)
See all 3072 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 8 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
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 QwikSIM Virtual Simulation System may be used by radiation oncologists, medical physicists, and medical dosimetrists for patient localization, image import and review, tumor and normal tissue delineation, and virtual simulation of treatment unit setup during the treatment planning process of external beam radiotherapy treatment. This information may then be exported to a treatment planning system for dose calculation.
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/K013531 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013531: Qwiksim Virtual Simulation System; Version 2.00.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013531
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026