# K122164: MR Vessellq Xpress

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Sep 7, 2012 after 49 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K040746: Mra-CMS, Medis Medical Imaging Systems BV (2004) Summary page 1.
- K041521: Volume Viewer Plus, General Electric Medical Systems (2004) Summary page 1.

## Indications for use
MR VesselIQ Xpress is intended to provide an optimized non-invasive application to facilitate vascular anatomy and pathology analysis from a set of DICOM 3.0 compliant 3D contrast- enhanced Magnetic Resonance Angiographic (MRA) images. MR VessellQ Xpress is a post processing application which can be used in the analysis of MRA data for the purpose of vascular disease assessment. This software is designed to assist radiologists and other clinicians in the evaluation and assessment of vascular anatomy and disease with the capability to provide a set of tools for visualizing directional vessel tortuosity, for sizing the vessel and for measuring areas of abnormalities within a vessel.

Source page: https://510kreport.com/device/K122164
Methodology: https://510kreport.com/methodology