# K040444: GE Signa 3.0T with Excite MR System

- Pathway: 510(k) (Special)
- Applicant: General Electric Co.
- Decided: Apr 14, 2004 after 85 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K990550 (1999). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 6 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022397: Signa 3.0T Magnetic Resonance System, GE Medical Systems (2002) Summary page 1.

## Most influential descendants
- K080820: Tem 3002G- HN Dual Tune Head Coil (2008), 0 descendants of its own
- K052200: Tem 3000 Head Coil (2005), 0 descendants of its own

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0614-2022: 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
- Aug 31, 2015 · Class II · Z-0256-2016: 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
- Jun 1, 2006 · Not classified · Z-0815-2007: To provide the 3.0T MRI systems users with the 8-channel brain coil the proper coil weighting software. The proper coil weighting factors for the eight-channel brain coil were not included in the soft

## Indications for use
The GE Signa® 3.OT with Excite is a whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa® 3.OT with Excite MR System is indicated for use as a diagnostic imaging device to produce transverse, 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® 3.OT with Excite MR systems 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/K040444
Methodology: https://510kreport.com/methodology