510(k) · Cleared
ClearedSomavision
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Varian Assoc., Inc. · KPQ System, Simulation, Radiation Therapy
Cleared on Feb 16, 2000 after a 184-day review. The FDA summary names its predicate without a number. 1 of the 311 devices in its family, counting itself, has a Class I recall. 310 later devices descend from it.
- Decided
- Feb 16, 2000
- Review
- 184 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- None
- Predicates
- 0
310 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.
- This deviceK992751 SomavisionVarian Assoc., Inc. · 2000
- 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 310 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 310 · 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) | K992751 | Somavision | Varian Assoc., Inc. | 2000 | — |
| +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 |
|---|---|---|
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 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? (1)
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 |
|---|---|---|---|
| * | — | General Electric Advantage Sim Named without a submission number |
What descends from it? (310)
See all 3102 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 | — |
What is it indicated for?
Somavision is an advanced treatment planning preparation workstation for the physician and
include high quality 3-D image capabilities. As part of the Varis Vision System, Somavision integrates treatment palnning in the overall therapy process, while taking advantage of the Varian Viston database.
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/K992751 · printed Nov 4, 2026
Cite this page
510(k) Report. “K992751: Somavision.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K992751
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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