510(k) · Cleared
ClearedIkoengelo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ikoetech, LLC · KPQ System, Simulation, Radiation Therapy
Cleared on Jun 5, 2006 as substantially equivalent to K013531 (Impac Medical Systems, Inc., 2001) after a 55-day review. Its family tree reaches back 2 generations to 1992. 1 of the 304 devices in its family, counting itself, has a Class I recall. 299 later devices descend from it.
- Decided
- Jun 5, 2006
- Review
- 55 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923851 (1992). 4 ancestors in all. 299 later devices descend from it, 4 citing it directly. 1 of the 304 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK923851 Acqsim Simulator/LocalizerPhilips Medical Systems (Cleveland), Inc. · 1992
- 1 generation backK013531 Qwiksim Virtual Simulation System; Version 2.00Impac Medical Systems, Inc. · 2001
- This deviceK061006 IkoengeloIkoetech, LLC · 2006
- Descendant · cites it directly · 287 of its ownK071964 Mim 4.1 (Seastar)Mimvista Corp. · 2007 · Recalled
- Descendant · cites it directly · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 2 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
- Descendant · 2 generations on · 79 of its ownK103576 Mim 5.2 (Brachy)Mim Software, Inc. · 2011
- Descendant · 3 generations on · 76 of its ownK101749 Syngo Trued SoftwareSiemens Medical Solutions · 2010
Showing 5 of 299 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…7 generations on · 2025
Most influential descendants
Showing 5 of 299 · See all- K071964Mim 4.1 (Seastar)Mimvista Corp. · 2007 · cites it directly287descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · cites it directly201descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 2 generations on200descendants
- K103576Mim 5.2 (Brachy)Mim Software, Inc. · 2011 · 2 generations on79descendants
- K101749Syngo Trued SoftwareSiemens Medical Solutions · 2010 · 3 generations on76descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923851 | Acqsim Simulator/Localizer | Philips Medical Systems (Cleveland), Inc. | 1992 | — |
| −1 | K013531 | Qwiksim Virtual Simulation System; Version 2.00 | Impac Medical Systems, Inc. | 2001 | — |
| 0 (this device) | K061006 | Ikoengelo | Ikoetech, LLC | 2006 | — |
| +1 | K071964 | Mim 4.1 (Seastar) | Mimvista Corp. | 2007 | 2 |
| +1 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +2 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
| +2 | K103576 | Mim 5.2 (Brachy) | Mim Software, Inc. | 2011 | — |
| +3 | K101749 | Syngo Trued Software | Siemens Medical Solutions | 2010 | — |
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 |
|---|---|---|
| 2007 | 2 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 7 | 0 |
| 2013 | 5 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 10 | 0 |
| 2017 | 12 | 0 |
| 2018 | 22 | 0 |
| 2019 | 20 | 0 |
| 2020 | 25 | 0 |
| 2021 | 21 | 0 |
| 2022 | 27 | 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 |
|---|---|---|---|
| * | K013531 | Qwiksim Virtual Simulation System; Version 2.00Summary page 1…(713) 600-2411 Predicate: IMPAC Medical Systems, Inc. QwikSIM Virtual Simulation System, 5 10(k) #: K013531. Device Description: The IKOEngelo device is a software system that will assist radiation… | 2001 |
What descends from it? (299)
See all 2994 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 · 7 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K071964 (Mimvista Corp., 2007) has gone furthest, with 287 descendants of its own.
- 1 other device also cites its predicate K013531.
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 IKOEngeloTM System is indicated for use by radiation oncologists,
medical physicists, and medical dosimetrists for tumor and normal tissue contour
delineation to support the radiotherapy treatment planning process. The resulting
information may then be exported to a treatment planning system for dose
calculation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061006 · printed Nov 4, 2026
Cite this page
510(k) Report. “K061006: Ikoengelo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K061006
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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