510(k) · Cleared
Recalled · 2010Advantage Sim
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · KPQ System, Simulation, Radiation Therapy
Cleared on Nov 13, 1995 after a 207-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 349 devices in its family, counting itself, has a Class I recall. 348 later devices descend from it. It has been recalled once.
- Decided
- Nov 13, 1995
- Review
- 207 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- 1
- Predicates
- 0
348 later devices descend from it, 4 citing it directly. 1 of the 349 devices in this family, counting this one, has a Class I recall.
- This deviceK951830 Advantage SimGeneral Electric Co. · 1995
- Descendant · cites it directly · 307 of its ownK013531 Qwiksim Virtual Simulation System; Version 2.00Impac Medical Systems, Inc. · 2001
- Descendant · 2 generations on · 299 of its ownK061006 IkoengeloIkoetech, LLC · 2006
- Descendant · 3 generations on · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · cites it directly · 217 of its ownK021780 Advantage Sim 6.0General Electric Medical Systems · 2002 · Recalled
- Descendant · 2 generations on · 216 of its ownK032915 Advantage 4D OptionGe Medical Systems, LLC · 2003
Showing 5 of 348 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 348 · See all- K013531Qwiksim Virtual Simulation System; Version 2.00Impac Medical Systems, Inc. · 2001 · cites it directly307descendants
- K061006IkoengeloIkoetech, LLC · 2006 · 2 generations on299descendants
- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · 3 generations on287descendants
- K021780Advantage Sim 6.0General Electric Medical Systems · 2002 · cites it directly217descendants
- K032915Advantage 4D OptionGe Medical Systems, LLC · 2003 · 2 generations on216descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K951830 | Advantage Sim | General Electric Co. | 1995 | — |
| +1 | K013531 | Qwiksim Virtual Simulation System; Version 2.00 | Impac Medical Systems, Inc. | 2001 | — |
| +2 | K061006 | Ikoengelo | Ikoetech, LLC | 2006 | — |
| +3 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +1 | K021780 | Advantage Sim 6.0 | General Electric Medical Systems | 2002 | 1 |
| +2 | K032915 | Advantage 4D Option | Ge Medical Systems, LLC | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2005 | 2 | 0 |
| 2006 | 5 | 0 |
| 2007 | 5 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 7 | 0 |
| 2012 | 9 | 0 |
| 2013 | 7 | 0 |
| 2014 | 11 | 0 |
| 2015 | 9 | 0 |
| 2016 | 11 | 0 |
| 2017 | 12 | 0 |
| 2018 | 23 | 0 |
| 2019 | 20 | 0 |
| 2020 | 26 | 0 |
| 2021 | 24 | 0 |
| 2022 | 28 | 0 |
| 2023 | 26 | 0 |
| 2024 | 28 | 0 |
| 2025 | 35 | 1 |
| 2026 | 34 | 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.
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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (348)
See all 3484 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 24, 2010 | Not classified | Z-1473-2011 | Software design | GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or the Isocenter Move mode feature is used in combination with specified other functions of… |
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?
- Of its descendants, K013531 (Impac Medical Systems, Inc., 2001) has gone furthest, with 307 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/K951830 · printed Nov 4, 2026
Cite this page
510(k) Report. “K951830: Advantage Sim.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K951830
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026