# K113490: Optima MR450W

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Jan 13, 2012 after 51 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 3 (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.
44 later devices descend from it; 1 cites it directly.
5 of 69 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K091536: Optima MR450W, Ge Medical Systems, LLC (2009) Summary page 1.

## Most influential descendants
- 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
- 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
- May 11, 2017 · Class II · Z-3024-2017: Possible incorrect wiring of the Uninterruptable Power Supply, which could contribute to a potential shock hazard.
- 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

## Indications for use
The OptimaTm MR4S0w 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 anid/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 OptimaTm MR4S0w reflect the spatial distribution or molecular environment of nuclei exhibiting magnetic resonance. Those images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.

Source page: https://510kreport.com/device/K113490
Methodology: https://510kreport.com/methodology