# K013636: Signa Infinity MR System with Excite Technology

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: Jan 24, 2002 after 80 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 12 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K962061 (1996). 3 ancestors in all.
100 later devices descend from it; 1 cites it directly.
3 of 104 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012200: 1.5T Infinity Twinspeed MR System, GE Medical Systems (2001) Summary page 1.

## Most influential descendants
- K041476: GE Signa Excite 1.5T MR System, GE Signa Excite 3.0T MR System (2004), 99 descendants of its own
- 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

## Recalls of this device
- Dec 23, 2021 · Class II · Z-0605-2022: The magnetic resonance systems could potentially have a cryogen ventilation system that does not meet the venting requirements.
- Nov 15, 2018 · Class II · Z-0693-2019: Possible incorrect software version loaded.
- 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-0255-2016: 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-1432-2011: 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
- May 11, 2009 · Not classified · Z-0462-2011: Signa MR Excite" 1.5T system containing 11.1_M4_0818.a software, associated with 2D Fast Spin Echo based pulse sequences (2D FSE-XL, 2D FRFSE-XL, 2D FSE-IR, 2D T2FLAIR and 2D T1FLAIR) may experience a

## Indications for use
The GE Signa Infinity line of products are whole body magnetic resonance scanners designed to support high resolution, high signal-to-noise ratio and short scan times. The Signa Infinity 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 Infinity 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/K013636
Methodology: https://510kreport.com/methodology