# K161567: SIGNA Voyager

- Pathway: 510(k) (Traditional)
- Applicant: GE Healthcare
- Decided: Sep 1, 2016 after 86 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K971684 (1997). 32 ancestors in all.
4 later devices descend from it; 2 cite 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)
- K160621: SIGNAPioneer, GE Healthcare (2016) Summary page 6.
- K142085: Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5T, Ge Medical Systems, LLC (2014) Summary page 6.

## Most influential descendants
- K192426: Signa Voyager, Signa Voyager Quantum (2019), 1 descendant of its own
- K183621: EMMA 1.5T MRI System (2019), 1 descendant of its own
- K233728: SIGNA Champion (2024), 0 descendants of its own
- K222259: NEONA 1.5T MRI System (2023), 0 descendants of its own

## Recalls of this device
- Jun 20, 2025 · Class II · Z-2300-2025: GE HealthCare has become aware that for certain MR systems (SIGNA Artist, SIGNA Voyager, Discovery MR450 1.5T, Optima MR450w 1.5T, SIGNA Architect, SIGNA Premier, SIGNA UHP, Discovery MR750 3.0T, Disc
- Dec 23, 2021 · Class II · Z-0599-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Aug 26, 2021 · Class II · Z-0138-2022: Under certain conditions, some slices may be missing which can lead to a gap of anatomy in the 3D Volume images.
- Jun 4, 2021 · Class II · Z-2062-2021: GE Healthcare has recently become aware of an issue on the affected products listed below where the "Patient Orientation" button may inadvertently be clicked when intending to click on the "Save RX" b

## Indications for use
The SIGNA Voyager is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan time imaging. The SIGNA Voyager is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique images, spectroscopic images and/or spectra, dynamic images, and parametric maps of the internal structures and organs of the entire body. Body structures for evaluation include, but are 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 the SIGNA Voyager reflect the spatial distribution and/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/K161567
Methodology: https://510kreport.com/methodology