# K041476: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System

- Pathway: 510(k) (Special)
- Applicant: Ge Medical Systems, LLC
- Decided: Jun 17, 2004 after 14 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 15 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K962061 (1996). 9 ancestors in all.
99 later devices descend from it; 3 cite it directly.
4 of 109 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013636: Signa Infinity MR System with Excite Technology, GE Medical Systems (2002) Summary page 1.
- K030874: GE 3.0T Signa Infinity Twinspeed with Excite MR System, General Electric Co. (2003) Summary page 1.

## Most influential descendants
- K052293: GE 1.5T and 3.0T Signa HDX MR System (2005), 90 descendants of its own
- 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

## Recalls of this device
- Feb 18, 2022 · Class II · Z-0858-2022: There is potential for the images to be flipped left to right.
- Dec 23, 2021 · Class II · Z-0615-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- 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
- Mar 30, 2018 · Class II · Z-2527-2018: There is a potential safety issue with the table transfer release of the MR Surgical Suite System which may cause an unexpected loss of function of the patient transfer mechanism that allows the patie
- Aug 31, 2015 · Class II · Z-0257-2016: 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
- Jul 10, 2015 · Class II · Z-2339-2015: A gradient cable in the ACGD cabinet may be missing a spacer that prevents connecting the gradient cable terminals in the wrong polarity on X gradient amplifier. This could cause images to be flipped 
- Mar 9, 2015 · Class II · Z-1305-2015: GE Healthcare has become aware of a potential safety issue involving MRI systems due to software versions not being maintained properly at some sites.
- Jan 7, 2015 · Class I · Z-1035-2015: At certain sites, the MRU may not be connected to the magnet. In emergency situations, a disconnected MRU could delay removal of a ferrous object from the magnet, potentially resulting in life-threate
- 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
- Nov 9, 2010 · Not classified · Z-1429-2011: 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 (
- Dec 14, 2007 · Not classified · Z-1891-2008: 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-2211-2008: 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® Excite 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® Excite 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® Excite 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/K041476
Methodology: https://510kreport.com/methodology