# K251399: SIGNA™ Sprint

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Sep 11, 2025 after 128 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.
1 later device descends 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)
- K193282: SIGNA Premier, Ge Healthcare (Ge Medical Systems, LLC) (2020) Summary page 5.

## Most influential descendants
- K253779: SIGNA™ Sprint Select (2026), 0 descendants of its own

## Indications for use
The SIGNA™ Sprint 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™ Sprint 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/K251399
Methodology: https://510kreport.com/methodology