# K161397: MAGiC

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Aug 31, 2016 after 104 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: 13 generations back to K971684 (1997). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
5 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142085: Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5T, Ge Medical Systems, LLC (2014) Summary page 4.

## Most influential descendants
- K162943: SyMRI (2017), 0 descendants of its own

## Indications for use
MAGiC (MAGnetic resonance image Compilation) is a software option based on a combination of acquisition and post processing software that is intended for use on GE imaging platforms. MAGiC generates multiple image contrasts from a single acquisition scan. MAGiC enables post-acquisition image contrast adjustment. MAGiC also allows for the generation of parametric maps for further analysis of MRI acquisition data. MAGiC is indicated for head imaging. When interpreted by a trained physician, MAGiC images can provide information useful in determining diagnosis.

Source page: https://510kreport.com/device/K161397
Methodology: https://510kreport.com/methodology