# K143485: iGuide 2.1

- Pathway: 510(k) (Traditional)
- Applicant: Medical Intelligence Medizintechnik GmbH
- Decided: Mar 4, 2015 after 86 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K072079 (2007). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072079: Iguide System, Medical Intelligence Medizintechnik-GmbH-An Elekta (2007) Summary page 4.

## Recalls of this device
- Jun 19, 2017 · Class II · Z-3017-2017: Incorrect PEC values.

## 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/K143485
Methodology: https://510kreport.com/methodology