# K082607: Mri-Plaque View, Version 1.1.2003

- Pathway: 510(k) (Traditional)
- Applicant: Vpdiagnostics, Inc.
- Decided: Dec 5, 2008 after 88 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: 11 generations back to K913770 (1991). 44 ancestors in all.
No later device cites it as a predicate yet.
0 of 45 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 1.
- K073156: Qplaque MR, Medis Medical Imaging Systems BV (2008) Summary page 1.

## Indications for use
The MRI-PlaqueView software provides a set of post-processing tools to assist trained cardiologists and radiologists in the quantitative analysis of atherosclerotic carotid arteries from 1.5T or 3.OT magnetic resonance imaging (MRI) studies acquired with a combination of one or more contrast weightings such as TI, T2, Proton Density, and Time of Flight. Users of MRI-PlaqueView perform semi- automatic delineation of lumen and outer vessel wall boundaries. Users may also perform semi-automatic, user configurable segmentation or manual drawing for delineation of atherosclerotic plaque components within the vessel wall. Users may edit the results on the fly. The software enables length, thickness, area, and volume measurements of the vessel wall as well as quantification of user-indicated areas. MRI-PlaqueView further aids in the visualization of atherosclerotic arteries (for example, through maximum intensity projections) of MRI data and color-coded maps of segmented arteries. When interpreted by a trained physician, the output of this image analysis toolbox can be used to support the decision-making process in clinical practice or to support investigations in clinical research and trials.

Source page: https://510kreport.com/device/K082607
Methodology: https://510kreport.com/methodology