# K052293: GE 1.5T and 3.0T Signa HDX MR System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Sep 21, 2005 after 29 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 21 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K962061 (1996). 10 ancestors in all.
90 later devices descend from it; 7 cite it directly.
4 of 101 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041476: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System, Ge Medical Systems, LLC (2004) Summary page 1.

## Most influential descendants
- K081028: Signa 3.0T MR750 System (2008), 70 descendants of its own
- K083147: Discovery MR450 (2008), 69 descendants of its own
- K091536: Optima MR450W (2009), 59 descendants of its own
- K103327: Discovery MR750W 3.0T (2011), 52 descendants of its own
- K113490: Optima MR450W (2012), 44 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
- Jun 7, 2018 · Class II · Z-0112-2019: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data
- Jun 7, 2018 · Class II · Z-0110-2019: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data
- Jun 7, 2018 · Class II · Z-0111-2019: The latest on-site software version may not have been reinstalled at some sites after service activities were performed resulting in images possibly flipped left/right and/or there can be patient data
- May 11, 2017 · Class II · Z-3027-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Aug 31, 2015 · Class II · Z-0258-2016: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling sugge
- Aug 31, 2015 · Class II · Z-0259-2016: When performing head or neck scans, the currently displayed SAR values could be lower than the actual SAR in the head as predicted by SAR modeling. The predicted HEAD SAR value from the modeling sugge
- Jun 8, 2012 · Class II · Z-1207-2013: GE Healthcare has recently become aware of a Reformat Image Flip Issue associated with GE MR Products. The axial and coronal reformatted images from a sagittal 3D series (such as with applications of 
- Nov 21, 2011 · Class II · Z-1943-2013: Screen save images are included in wrong exam due to duplicate UID creation. This may cause a safety issue due to a potential patient data mismatch.While the issue has only been observed at one custom
- May 10, 2011 · Class II · Z-0935-2013: An error on the SR Viewer Reporting Tool in which edits can be made on a report and can be saved into incorrect reports.
- Nov 9, 2010 · Not classified · Z-1428-2011: GE Healthcare has become aware of a potential issue associated with the gradient cables being inadvertently swapped while servicing the gradients on some GE Healthcare MR Systems that may impact patie
- Oct 6, 2009 · Not classified · Z-0592-2010: GE Healthcare has recently become aware that the use of Confirma, Inc.'s CADstream in conjunction with the GE Healthcare's PURE (Phased Array Uniformity Enhancement) software for dynamic MRI imaging (
- Mar 28, 2008 · Not classified · Z-2225-2008: Possible misdiagnosis or inappropriate treatment based on the image. Signal homogeneity may be affected when BRAVO applications are set with IR Prep off. The concern is that signal inhomogeneity can r
- Dec 14, 2007 · Not classified · Z-1890-2008: GE healthcare has become aware of an artifact which could affect the diagnostic capability associated with the 3.0T Propeller T2 Flair application of the 3.0T Signa HDx scanner.
- Oct 1, 2007 · Not classified · Z-2210-2008: A software issue that may result in misregistration of functional and anatomical images associated with the 3.0T BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner.

## Indications for use
The GE Signa® HDx MR system is a whole body magnetic resonance scanner designed to support high resolution, high signal-to-noise ratio, and short scan times. The Signa® HDx MR system is indicated for use as a diagnostic imaging device to produce axial sagittal, coronal and oblique images, spectroscopic images, and/or spectra, dynamic images of the internal structures and organs 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. The images produced by the Signa e HDx system reflect the spatial distribution of protons (hydrogen 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/K052293
Methodology: https://510kreport.com/methodology