# K241242: Signa Magnus

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Oct 17, 2024 after 167 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: 18 generations back to K971684 (1997). 35 ancestors in all.
No later device cites it as a predicate yet.
5 of 36 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193282: SIGNA Premier, Ge Healthcare (Ge Medical Systems, LLC) (2020) Summary page 5.

## Indications for use
SIGNA MAGNUS system is a head-only magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, diffusion-weighted imaging, and short scan times. SIGNA MAGNUS is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images, parametric maps, and/or spectra, dynamic images of the structures and/or functions of the head, neck, TMJ, and limited cervical spine on patients 6 years of age and older. Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA MAGNUS reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K241242
Methodology: https://510kreport.com/methodology