# K211980: SIGNA Prime

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare (Tianjin) Company Limited
- Decided: Jan 16, 2022 after 205 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K971684 (1997). 34 ancestors in all.
2 later devices descend from it; 1 cites it directly.
5 of 37 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143251: SIGNA Creator, SIGNA Explorer, Ge Healthcare (Ge Medical Systems, LLC) (2015) Summary page 4.

## Most influential descendants
- K223439: SIGNA Victor (2023), 1 descendant of its own
- K250379: SIGNA Prime Elite (2025), 0 descendants of its own

## Recalls of this device
- Jun 14, 2024 · Class II · Z-2479-2024: GE HealthCare has become aware that for certain MR systems, the system predicted B1+RMS value can exceed the B1+RMS user prescribed limit when scanning in Low SAR Mode and the following two conditions
- Mar 4, 2022 · Class II · Z-0983-2022: During the de-installation of an MR system magnet, if all rigging and hardware that attach to the magnet for transportation are not properly installed and secured, the magnet may fall, leading to pote

## Indications for use
The SIGNA Prime is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. It 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 entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal regions of the body. Depending on the region of interest being imaged, contrast agents may be used. The images produced by SIGNA Prime 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/K211980
Methodology: https://510kreport.com/methodology