# K061006: Ikoengelo

- Pathway: 510(k) (Traditional)
- Applicant: Ikoetech, LLC
- Decided: Jun 5, 2006 after 55 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). 4 ancestors in all.
299 later devices descend from it; 4 cite it directly.
1 of 304 devices in its family (counting itself) has 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.

## Most influential descendants
- K071964: Mim 4.1 (Seastar) (2007), 287 descendants of its own
- K071950: Syngo Trued (2007), 201 descendants of its own
- K091373: Syngo Trued (2009), 200 descendants of its own
- K103576: Mim 5.2 (Brachy) (2011), 79 descendants of its own
- K101749: Syngo Trued Software (2010), 76 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K061006
Methodology: https://510kreport.com/methodology