# K163281: FastStroke

- Pathway: 510(k) (Traditional)
- Applicant: Gef Medical Systems Scs
- Decided: Jan 26, 2017 after 66 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: 3 generations back to K871859 (1987). 6 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 4.

## Most influential descendants
- K193289: FastStroke, CT Perfusion 4D (2020), 1 descendant of its own
- 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.

Source page: https://510kreport.com/device/K163281
Methodology: https://510kreport.com/methodology