# K193289: FastStroke, CT Perfusion 4D

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Nov 12, 2020 after 351 days
- Product code: JAK (System, X-Ray, Tomography, Computed)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K871859 (1987). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163281: FastStroke, Gef Medical Systems Scs (2017) Summary page 6.
- K052839: CT Perfusion 4, GE Healthcare (2006) Summary page 6.

## Most influential descendants
- K242624: Medical Image Post-processing Software (uOmnispace.CT) (2025), 0 descendants of its own

## Indications for use
FastStroke is a CT image analysis software package that assists in the analysis and visualization of CT data derived from DICOM 3.0 compliant CT scans. FastStroke is intended for the purpose of displaying vasculature of the head and neck at different time points of enhancement. The software will assist the user by providing optimized display settings to enable fast review of the images in synchronized formats, aligning the display of the images to the order of the scans and linking together multiple groups of scans. In addition, the software fuses the vascular information from different time points into a single colorized view. This multiphase information can aid the physician in visualizing the presence or absence of collateral vessels in the brain. Collateral vessel information may aid the physician in the evaluation of stroke patients. CT perfusion 4D 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 (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/K193289
Methodology: https://510kreport.com/methodology