# K083591: Ikoengelo, Version 2

- Pathway: 510(k) (Special)
- Applicant: Ikoetech, LLC
- Decided: Dec 29, 2008 after 25 days
- Product code: KPQ (System, Simulation, Radiation Therapy)
- Device class: 2
- Regulation: 21 CFR 892.5840
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K923851 (1992). 5 ancestors in all.
19 later devices descend from it; 3 cite it directly.
0 of 25 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013531: Qwiksim Virtual Simulation System; Version 2.00, Impac Medical Systems, Inc. (2001) Summary page 1.
- K973233: Image Fusion and Review System, Adac Laboratories (1997) Summary page 1.

## Most influential descendants
- K111311: Segmentation Assistant for Prostate-Auto Contouring (2011), 9 descendants of its own
- K132944: Advantagesim MD MR Pelvic Organ at Risk Segmentation (2014), 7 descendants of its own
- K151233: Monaco (2015), 6 descendants of its own
- K183037: Monaco RTP System (2018), 5 descendants of its own
- K112778: Smart Segmentation-Knowledge Based Contouring (2011), 5 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K083591
Methodology: https://510kreport.com/methodology