# K133526: Mdixon-Quant

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Feb 12, 2014 after 89 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: 7 generations back to K962061 (1996). 13 ancestors in all.
No later device cites it as a predicate yet.
4 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103411: Ideal IQ Software Option, GE Medical Systems (2011) Summary page 2.

## Indications for use
mDIXON-Quant: is a software option intended for use on Achieva and Ingenia 1.5T & 3.0T MR Systems is a non-invasive triglyceride fat fraction calculation is a 3D, single breath-hold acquisition and reconstruction technique allows for water-fat separation generating Water-only, Fat-only images as well as Out-phase and In-phase images is indicated for magnetic resonance imaging of the liver

Source page: https://510kreport.com/device/K133526
Methodology: https://510kreport.com/methodology