# K103327: Discovery MR750W 3.0T

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Japan Corporation
- Decided: Sep 30, 2011 after 322 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K971684 (1997). 24 ancestors in all.
52 later devices descend from it; 3 cite it directly.
5 of 77 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081028: Signa 3.0T MR750 System, Ge Medical Systems, LLC (2008) Summary page 1.
- K091536: Optima MR450W, Ge Medical Systems, LLC (2009) Summary page 1.

## Most influential descendants
- K130115: Discovery MR750W 3.0T (2013), 43 descendants of its own
- K132376: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750W 3.0T, Optima MR450W 1.5T (2013), 42 descendants of its own
- K142085: Discovery MR750 3.0T ,Discovery MR450 1.5T, Discovery MR750 3.0T,Optima MR450W 1.5T (2014), 40 descendants of its own
- K160618: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T (2016), 16 descendants of its own
- K163331: Discovery MR750 3.0T; Discovery MR750w 3.0T;Discovery MR450 1.5T; Discovery MR450w 1.5T; SIGNA Architect and SIGNA Artist (2017), 15 descendants of its own

## Recalls of this device
- Sep 8, 2020 · Class II · Z-0127-2021: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
- Jun 8, 2016 · Class II · Z-2131-2016: GE Healthcare has recently become aware of a potential safety issue with the patient bore heating on the Discovery MR750w. A small area on the bore surface, which is normally accessible to the patient
- 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
- 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
- Apr 23, 2012 · Class II · Z-1100-2013: GE Healthcare has recently become aware of a potential issue due to image flip in frequency encoding direction associated with a specific workflow of your Discovery MR750w system. Image flip issue in 

## Indications for use
The Discovery MR750w 3.0T 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 Discovery MR750w 3.0T 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/K103327
Methodology: https://510kreport.com/methodology