# K062611: Iguide System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Intelligence Medizintechnik-GmbH-An Elekta
- Decided: Sep 20, 2006 after 15 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003285 (2001). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003285: Exac Trac 2.0 (Novalis Body Module), Brainlab AG (2001) Summary page 1.

## Most influential descendants
- K112692: Identify (2012), 6 descendants of its own
- K190137: Identify (2019), 5 descendants of its own
- K192968: Identify (2019), 4 descendants of its own
- K210835: Identify (2021), 3 descendants of its own
- K230576: Identify (2023), 2 descendants of its own

## Indications for use
The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

Source page: https://510kreport.com/device/K062611
Methodology: https://510kreport.com/methodology