Advantage Sim 6.0

• • Terminated Z-1473-2011 FDA Unclassified (pre-2012) ·initiated 24 Nov 2010 ·on shared 510(k) K021780

  GE Healthcare has become aware that inconsistent DRR (Digitally Reconstructed Radiographic) visualization may occur when the blended DRR feature or the Isocenter Move mode feature is used in combination with specified other functions of the AdvantageSim application on Advantage Workstation. These inconsistencies may affect patient safety. Other AdvantageSim functions are not affected.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K021780 ↗

FDA Product Code

KPQ

Device Class

Class II

Regulation

21 CFR Part 892.5840

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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