# K072079: Iguide System

- Pathway: 510(k) (Traditional)
- Applicant: Medical Intelligence Medizintechnik-GmbH-An Elekta
- Decided: Aug 14, 2007 after 15 days
- Product code: IYE (Accelerator, Linear, Medical)
- Device class: 2
- Regulation: 21 CFR 892.5050
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) iGUIDE System: named in the summary without a submission number

## Most influential descendants
- K143485: iGuide 2.1 (2015), 0 descendants of its own

## Recalls of this device
- Jul 18, 2019 · Class II · Z-2082-2019: Sometimes, although the HexaPOD has reached the target position, the Constant Correlation Check (CCC) can be too sensitive and iGUIDE may incorrectly demand a verification scan.
- Jun 19, 2019 · Class II · Z-2230-2019: Potential for iGUIDE to incorrectly monitor the 3D position.
- Aug 18, 2016 · Class II · Z-2691-2016: Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.
- May 12, 2016 · Class II · Z-1705-2016: If by mistake the initial pre-treatment imaging was performed BEFORE the HexaPOD was moved to the DRIVE (*START) position, iGUIDE offers the possibility to branch into a specific catch-up workflow, wh
- May 29, 2014 · Class II · Z-1807-2014: A bug in the software prevents the iGUIDE software from logging off.

## 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/K072079
Methodology: https://510kreport.com/methodology