Iguide System

• • Terminated Z-2082-2019 FDA Class II ·initiated 18 Jul 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.

• • Terminated Z-2230-2019 FDA Class II ·initiated 19 Jun 2019

  Potential for iGUIDE to incorrectly monitor the 3D position.

• • Terminated Z-2691-2016 FDA Class II ·initiated 18 Aug 2016

  Potentially unrecognized incorrect position of the treatment couch in 3D workflow, i.e. the HexaPOD has not moved fully to the 3D position.

• • Terminated Z-1705-2016 FDA Class II ·initiated 12 May 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, which was implemented to use the initial scan data.

• • Terminated Z-1807-2014 FDA Class II ·initiated 29 May 2014

  A bug in the software prevents the iGUIDE software from logging off.

510(k) Number

K072079 ↗

FDA Product Code

IYE

Device Class

Class II

Regulation

21 CFR Part 892.5050

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

• Bodyfix

  Class II

  FDA 510(k) K013391 Active Cleared 11 Jan 2002

• BodyFIX System

  Class II

  FDA 510(k) K121530 Active Cleared 20 Jun 2012

• Headfix

  Class II

  FDA 510(k) K030439 Active Cleared 8 May 2003

• Fraxion

  Class II

  FDA 510(k) K112210 Active Cleared 22 Nov 2011

• Iguide System

  Class II

  FDA 510(k) K062611 Active Cleared 20 Sep 2006

• iGuide 2.1

  Class II

  FDA 510(k) K143485 Active Cleared 4 Mar 2015

See all devices from Medical Intelligence Medizintechnik GmbH →