# K091536: Optima MR450W

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jul 17, 2009 after 52 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 8 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K971684 (1997). 23 ancestors in all.
59 later devices descend from it; 3 cite it directly.
5 of 83 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K083147: Discovery MR450, Ge Medical Systems, LLC (2008) Summary page 1.

## Most influential descendants
- 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
- K123522: Optima MR450W (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

## Recalls of this device
- Sep 8, 2020 · Class II · Z-0128-2021: Potential electrical arc flash within the Power Gradient & RF (PGR) Cabinet.
- May 11, 2017 · Class II · Z-3024-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- 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
- 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-3121-2011: 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-1377-2011: 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

## Indications for use
The Optima MR450w is a whole body magnetic resonance scanner designed to support high resolution and high signal-to-noise ratio images in short exam times. It is indicated for use as a diagnostic imaging device to produce axial, sagittal, coronal, and oblique anatomical images, spectroscopic data, parametric maps, or dynamic images of the structures or functions of the entire body. The indication for use includes, but is 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 Optima MR450w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. These images and spectra, when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K091536
Methodology: https://510kreport.com/methodology