510(k) · Cleared
ClearedAcqsim Simulator/Localizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems (Cleveland), Inc. · KPQ System, Simulation, Radiation Therapy
Cleared on Oct 27, 1992 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 of the 355 devices in its family, counting itself, has a Class I recall. 354 later devices descend from it.
- Decided
- Oct 27, 1992
- Review
- 88 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- None
- Predicates
- 0
354 later devices descend from it, 7 citing it directly. 1 of the 355 devices in this family, counting this one, has a Class I recall.
- This deviceK923851 Acqsim Simulator/LocalizerPhilips Medical Systems (Cleveland), Inc. · 1992
- 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 · 3 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 4 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 354 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…9 generations on · 2025
Most influential descendants
Showing 5 of 354 · 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
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 3 generations on201descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 4 generations on200descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K923851 | Acqsim Simulator/Localizer | Philips Medical Systems (Cleveland), Inc. | 1992 | — |
| +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 |
| +3 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +4 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 5 | 0 |
| 2007 | 4 | 0 |
| 2008 | 4 | 0 |
| 2009 | 6 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 8 | 0 |
| 2013 | 7 | 0 |
| 2014 | 9 | 0 |
| 2015 | 9 | 0 |
| 2016 | 12 | 0 |
| 2017 | 14 | 0 |
| 2018 | 23 | 0 |
| 2019 | 20 | 0 |
| 2020 | 28 | 0 |
| 2021 | 24 | 0 |
| 2022 | 28 | 0 |
| 2023 | 27 | 0 |
| 2024 | 27 | 0 |
| 2025 | 34 | 1 |
| 2026 | 33 | 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? (354)
See all 3547 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 · 9 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/K923851 · printed Nov 6, 2026
Cite this page
510(k) Report. “K923851: Acqsim Simulator/Localizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K923851
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026