# K052839: CT Perfusion 4

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Mar 10, 2006 after 154 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- 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 K010042 (2001). 1 ancestor in all.
43 later devices descend from it; 7 cite it directly.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K010042: CT Perfusion 2, General Electric Co. (2001) Summary page 1.

## Most influential descendants
- K073373: Syngo Volume Perfusion-CT Body (2007), 33 descendants of its own
- K073238: Syngo Volume Perfusion-CT Neuro (2008), 19 descendants of its own
- K122909: Syngo Single Source Dual Engery (2012), 13 descendants of its own
- K133677: Syngo CT Single Source Dual Energy (2014), 12 descendants of its own
- K150745: syngo.CT Single Source Dual Energy (2015), 11 descendants of its own

## Recalls of this device
- May 4, 2009 · Not classified · Z-1720-2009: 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 sa

## Indications for use
CT perfusion 4 is an image analysis software package that allows the user to produce dynamic image data and to generate information with regard to changes in image intensity over time. It supports the analysis of CT Perfusion images, obtained by cine imaging (in the head and body) after the intravenous injection of contrast, in calculation of the various perfusion-related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability). The results are displayed in a user-friendly graphic format as parametric images. This software will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes, which may be related to stroke or tumor angiogenesis and the treatment thereof.

Source page: https://510kreport.com/device/K052839
Methodology: https://510kreport.com/methodology