# K143251: SIGNA Creator, SIGNA Explorer

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare (Ge Medical Systems, LLC)
- Decided: Feb 4, 2015 after 84 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 14 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K971684 (1997). 33 ancestors in all.
3 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)
- K123417: Brivo MR355, Optima MR360, Ge Hangwei Medical Systems Co., Ltd. (2013) Summary page 4.
- 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
- K211980: SIGNA Prime (2022), 2 descendants of its own
- K223439: SIGNA Victor (2023), 1 descendant of its own
- K250379: SIGNA Prime Elite (2025), 0 descendants of its own

## Recalls of this device
- Jan 31, 2025 · Class II · Z-1242-2025: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enabl
- Jan 31, 2025 · Class II · Z-1239-2025: For certain MR systems, a scan can be resumed following a Power Monitor trip when the "6-minute average SAR" is above the limit indicated on the "SAR Display". The user interface may incorrectly enabl
- Jun 14, 2024 · Class II · Z-2475-2024: 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
- Jun 14, 2024 · Class II · Z-2476-2024: 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
- Jun 14, 2024 · Class II · Z-2473-2024: 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
- Jun 14, 2024 · Class II · Z-2472-2024: 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
- Jun 14, 2024 · Class II · Z-2470-2024: 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
- Dec 23, 2021 · Class II · Z-0596-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Dec 23, 2021 · Class II · Z-0597-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Aug 26, 2021 · Class II · Z-0137-2022: 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-2058-2021: 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
- Jun 4, 2021 · Class II · Z-2059-2021: 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
- May 11, 2017 · Class II · Z-3026-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Aug 31, 2016 · Class II · Z-2731-2016: GE Healthcare is conducting a recall dealing with an incorrect RF Power Monitor Function involving SIGNA CREATOR and SIGNA EXPLORER which could result in higher than expected thermal dose to the patie

## Indications for use
1.5T SIGNA Creator and 1.5T SIGNA Explorer 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 1.5T SIGNA Creator and 1.5T SIGNA Explorer reflects 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/K143251
Methodology: https://510kreport.com/methodology