# K073156: Qplaque MR

- Pathway: 510(k) (Traditional)
- Applicant: Medis Medical Imaging Systems BV
- Decided: Mar 4, 2008 after 117 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K913770 (1991). 43 ancestors in all.
21 later devices descend from it; 2 cite it directly.
0 of 65 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050376: Prowin, Medical Technologies International, Inc. (2005) Summary page 1.
- K030223: Sonocalc, Sonometric Health, LLC (2003) Summary page 1.
- K043111: Plaqueview Software, Model CSPV-0001A, Toshiba America Medical Systems, In.C (2004) Summary page 1.
- K071331: Vitrea Version 4.0, Vital Images, Inc. (2007) Summary page 1.
- K033361: Viatronix V3D Vascular, Revision 1.0, Viatronix, Inc. (2003) Summary page 1.

## Most influential descendants
- K120636: Synapse 3D Cardiac Tools (2012), 19 descendants of its own
- K171222: Vitrea Software Toshiba Package; VSTP-001A (2017), 12 descendants of its own
- K173088: Vitrea Software Toshiba Package VSTP-001A (2018), 11 descendants of its own
- K183013: Vitrea Software Package, VSTP-001A (2018), 9 descendants of its own
- K192923: Vitrea Software Package (2020), 8 descendants of its own

## Indications for use
QPlaque MR is a post-processing software application that is intended to assist trained cardiologists and radiologists in the assessment of atherosclerosis. The software is intended in particular to aid in assessing vessel wall thickness and remodeling in the carotid arteries I QPlaque MR post-processes multi-spectral MR images to semi-automatically determine the boundaries of the lumen and outer vessel wall, and provides editing tools for manual drawing of plaque components. The software enables area and volume measurements of the vessel wall as well as quantification of user-indicated areas. QPlaque MR results can be used to support the decision-making process in clinical practice and to support conclusions in clinical trials.

Source page: https://510kreport.com/device/K073156
Methodology: https://510kreport.com/methodology