# K081028: Signa 3.0T MR750 System

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Apr 25, 2008 after 14 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 11 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K971684 (1997). 21 ancestors in all.
70 later devices descend from it; 2 cite it directly.
5 of 92 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.
- K072237: Magnetom Verio, Siemens Medical Solutions USA, Inc. (2007) Summary page 1.

## Most influential descendants
- 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
- K130115: Discovery MR750W 3.0T (2013), 43 descendants of its own

## Recalls of this device
- May 11, 2017 · Class II · Z-3025-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- Dec 7, 2015 · Class II · Z-0201-2019: GE Healthcare has recently become aware of a potential safety issue with the 3.0T 6 Channel Flex Coil used with the 3T MR750W Surgical Suite Scanners. Coil overheating can occur when the device is use
- Apr 23, 2014 · Class II · Z-1533-2014: GE Healthcare has recently become aware of a potential safety issue with certain GE MRI Products. Patient egress from the system can be delayed or impeded if the cradle release handle and/or cradle re
- Apr 2, 2014 · Class II · Z-1480-2014: Potential safety issue with gradient coil electromechanical connections associated with GE MR Products. Gradient coil electromechanical connections may loosen causing an increase in resistance. The in
- Aug 13, 2013 · Class II · Z-2291-2013: GE Healthcare has recently become aware of a potential safety issue due to exposed yellow foam on the end bells of Discovery MR450, Discovery MR750, and Optima MR450w products. The yellow foam strip u
- 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
- 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 
- Jul 29, 2011 · Not classified · Z-3122-2011: GE Healthcare has become aware of two potential safety issues associated with MR products (Optima MR450w, Discovery MR450, Discovery MR750, Brivo MR355, Optima MR360) that may impact patient safety. 1
- 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 18, 2010 · Not classified · Z-1375-2011: GE Healthcare has become aware that during certain service procedures, there is a potential for electric shock associated with the gradient cooling manifold hoses of your MR750, MR450, and MR450w MR s
- 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 (

## Indications for use
The GE Signa® MR750 System is 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 GE Signa® MR750 System reflect 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/K081028
Methodology: https://510kreport.com/methodology