510(k) · Cleared
ClearedIkoengelo, Version 2
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 Dec 29, 2008 as substantially equivalent to K013531 (Impac Medical Systems, Inc., 2001) and 1 other predicate after a 25-day review. Its family tree reaches back 2 generations to 1992. 19 later devices descend from it.
- Decided
- Dec 29, 2008
- Review
- 25 days
- Class
- Class II
- Product code
- KPQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K923851 (1992). 5 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- 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 deviceK083591 Ikoengelo, Version 2Ikoetech, LLC · 2008
- Descendant · cites it directly · 9 of its ownK111311 Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies) · 2011
- Descendant · 2 generations on · 7 of its ownK132944 Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
- Descendant · 3 generations on · 6 of its ownK151233 MonacoImpac Medical Systems, Inc. · 2015 · Recalled
- Descendant · 4 generations on · 5 of its ownK183037 Monaco RTP SystemElekta, Inc. · 2018 · Recalled
- Descendant · cites it directly · 5 of its ownK112778 Smart Segmentation-Knowledge Based ContouringVarian Medical Systems · 2011
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K111311Segmentation Assistant for Prostate-Auto ContouringOmisa Inc. (Segasist Technologies) · 2011 · cites it directly9descendants
- K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014 · 2 generations on7descendants
- K151233MonacoImpac Medical Systems, Inc. · 2015 · 3 generations on6descendants
- K183037Monaco RTP SystemElekta, Inc. · 2018 · 4 generations on5descendants
- K112778Smart Segmentation-Knowledge Based ContouringVarian Medical Systems · 2011 · cites it directly5descendants
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) | K083591 | Ikoengelo, Version 2 | Ikoetech, LLC | 2008 | — |
| +1 | K111311 | Segmentation Assistant for Prostate-Auto Contouring | Omisa Inc. (Segasist Technologies) | 2011 | — |
| +2 | K132944 | Advantagesim MD MR Pelvic Organ at Risk Segmentation | Ge Hungary Kft | 2014 | — |
| +3 | K151233 | Monaco | Impac Medical Systems, Inc. | 2015 | 9 |
| +4 | K183037 | Monaco RTP System | Elekta, Inc. | 2018 | 6 |
| +1 | K112778 | Smart Segmentation-Knowledge Based Contouring | Varian Medical Systems | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2026 | 1 | 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.
Planning a device in KPQ? 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? (2)
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…leared Version 1.0: IMPAC Medical Systems, Inc. QwikSIM Virtual Simulation System, 5 10(k) #: K013531. Predicate Device for Current Submitted Version 2.0: ADAC Laboratories… | 2001 |
| * | K973233 | Image Fusion and Review SystemSummary page 1…or Current Submitted Version 2.0: ADAC Laboratories Image Fusion and Review System, 510(k) #: K973233. Device Description: The IKOEngelo version 2.0 device is a software system upgraded from… | 1997 |
What descends from it? (19)
See all 193 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K111311 (Omisa Inc. (Segasist Technologies), 2011) has gone furthest, with 9 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. 2008, this device’s year, is highlighted.
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 IKOEngelo TM 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/K083591 · printed Nov 6, 2026
Cite this page
510(k) Report. “K083591: Ikoengelo, Version 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083591
Report an extraction error
Are you the manufacturer?
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