CT Perfusion 4

• • Terminated Z-1720-2009 FDA Unclassified (pre-2012) ·initiated 4 May 2009

  GE Healthcare has recently become aware of the need to adjust default settings associated with the use of CT Perfusion 4 on the Advantage Workstation, ST and PET/CT consoles that may impact patient safety. The default parameter settings in CT Perfusion 4 may not be optimal in the case of data acquired with longer time sampling intervals such as axial scans with inter scan delay (ISD) greater th

510(k) Number

K052839 ↗

FDA Product Code

JAK

Device Class

Class II

Regulation

21 CFR Part 892.1750

Advisory Committee

Radiology

FDA Decision

SESE Substantially Equivalent

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