# K024066: Infinion Software Features

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Feb 4, 2003 after 57 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: 1 generation back to K003573 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003573: Diffusion Tensor Imaging Option, Ge Medical Systems, Inc. (2001) Summary page 2.
- (no number) Philips (formerly Marconi's) Infinion 1.5T MR Imaging System: named in the summary without a submission number
- (no number) Philips Intera (R7.5) Software Package: named in the summary without a submission number

## Indications for use
The Infinion Software Features does not change the existing indications as defined below. The Infinion 1.5T MR Imaging System is indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (TI), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis. Diffusion tensor imaging produced magnetic resonance (MR) images whose contrast is dependent on the local diffusion coefficient of water. Diffusion tensor imaging can be used to image the directional dependence of the diffusion coefficient in tissue with restricted diffusion from tissues with normal diffusion.

Source page: https://510kreport.com/device/K024066
Methodology: https://510kreport.com/methodology