# K121676: 1.5T Signa HDXT 3.0T Signa HDXT Signa Vibrant

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Sep 20, 2012 after 105 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 10 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K971684 (1997). 25 ancestors in all.
5 later devices descend from it; 2 cite it directly.
5 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052293: GE 1.5T and 3.0T Signa HDX MR System, Ge Medical Systems, LLC (2005) Summary page 1.
- K103327: Discovery MR750W 3.0T, Ge Healthcare Japan Corporation (2011) Summary page 1.

## Most influential descendants
- K151212: Ziostation2 (2015), 2 descendants of its own
- K200327: Evry (2020), 1 descendant of its own
- K181892: Ziostation2 (2018), 1 descendant of its own
- K232981: Synq Software Version 1.3 (2023), 0 descendants of its own
- K200315: Ziostation2 (2020), 0 descendants of its own

## Recalls of this device
- Jun 14, 2024 · Class II · Z-2463-2024: 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-2471-2024: 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
- Feb 18, 2022 · Class II · Z-0860-2022: There is potential for the images to be flipped left to right.
- Dec 23, 2021 · Class II · Z-0603-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Aug 26, 2021 · Class II · Z-0141-2022: 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-2065-2021: 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
- Dec 23, 2019 · Class II · Z-0877-2020: It was identified that due to a potential installation workflow issue, the MR system date could be set incorrectly. The system s date and time setting are used to populate the DICOM header information
- Nov 15, 2018 · Class II · Z-0693-2019: Possible incorrect software version loaded.
- May 11, 2017 · Class II · Z-3028-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Apr 9, 2013 · Class II · Z-2266-2013: GE Healthcare has recently become aware of a potential safety issue due to non-unique series identifiers embedded in image headers of certain GE MR Products. For ClariView and Screen Save from GVTK (G

## Indications for use
The 1.5T Signa HDx family and 3.0T Signa HDx family are 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 the 1.5T Signa HDx family and 3.0T Signa HDx family 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/K121676
Methodology: https://510kreport.com/methodology