# K143128: mDIXON XD

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederlands B.V.
- Decided: Mar 20, 2015 after 141 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). 20 ancestors in all.
No later device cites it as a predicate yet.
8 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102344: Mdixon Software Option for Intera 1.5T, Achieva 1.5T & Achieva 3.0T MR Systems, Philips Medical Systems Nederland B.V. (2010) Summary page 5.

## Indications for use
mDIXON XD is a software option intended for use on Achieva, Ingenia 1.5T & 3T MR Systems. It is indicated for use in Magnetic Resonance Imaging of the human body. mDIXON XD is an enhanced 2-point fat-free mDIXON technology, available for gradient echo and spin echo acquisitions. mDIXON XD enables the combination of a fat-free technology with the MultiVane XD motion-free technique for anatomies such as head. mDIXON XD also enables subtractionless MR Angiography in areas of the body where exogenous contrast media has been approved for MR imaging.

Source page: https://510kreport.com/device/K143128
Methodology: https://510kreport.com/methodology