# K111222: Mri-Q System

- Pathway: 510(k) (Traditional)
- Applicant: Resonance Health Analysis Services Pty, Ltd.
- Decided: Jul 28, 2011 after 87 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: 4 generations back to K940172 (1994). 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)
- K043271: R2-Mri Analysis System, Inner Vision Biometrics Pty, Ltd. (2005) Summary page 2.
- K073194: Cmrtools and Plug-Ins Ventricular Tools & Thalassaemia Tools, Cardiovascular Imaging Solutions, Ltd. (2008) Summary page 2.

## Indications for use
The MRI-Q System is a software device that provides quantitative analysis of magnetic resonance image signal decay parameters in cardiac tissue. The device contains an image viewer for importing DICOM images, browsing through datasets and performing quantitative region of interest analysis. The software device has capability to measure the signal decay rate (R2*) and time (T 2 *) in heart tissue.

Source page: https://510kreport.com/device/K111222
Methodology: https://510kreport.com/methodology