# K152584: Stroke VCAR

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Jan 20, 2016 after 132 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.
No later device cites it as a predicate yet.
0 of 7 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.

## Indications for use
Stroke VCAR is a CT image analysis software package that provides information to physicians to assist them in the analysis and visualization of Brain CT data derived from DICOM 3.0 compliant CT scans. Stroke VCAR is designed for the purpose of segmenting and assessing intracerebral and intracranial hemorrhages in the brain using semi-automated tools on non-contrast CT exams. Additionally Stroke VCAR provides a set of workflow tools for the segmentation and visualization of aneurysms in the brain from contrast enhanced CT exams. It is intended for use by clinicians to process, review, archive, print and distribute CT studies. This software will assist the user by providing initial 3D segmentation, measurements and visualization of hemorrhages and aneurysm in the brain. The user has the ability to adjust, review and has to confirm the final segmentation.

Source page: https://510kreport.com/device/K152584
Methodology: https://510kreport.com/methodology