# K031230: GE Propeller Imaging Option for Mri

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems
- Decided: May 2, 2003 after 14 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K971055 (1997). 3 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972990: Magnetic Resonance Diagnostic System, GE Medical Systems (1998) Summary page 2.
- K944979: Magnetic Resonance Diagnostic Accessory, GE Medical Systems (1995) Summary page 2.

## Most influential descendants
- K113394: Mavric SL (2012), 1 descendant of its own
- K143253: O-MAR (2015), 0 descendants of its own
- K073081: Jet Software for Excelart Vantage Atlas-Z and Atlas-X (2007), 0 descendants of its own

## Indications for use
Propeller Imaging Option is a Fast Spin Echo (FSE) based sequence which employs a alternate k-space trajectory. 1. When used with diffUsionsensitizing gradients on a minimum of 3 axes, it will augment the standard Echo Planar Imaging (EPI) based difision imaging by providing improved image quality in areas of high susceptibility. This may aid the trained physician in the visualization of pathology in areas traditionally obscured by susceptibility artifacts. It is intended for use in anatomical regions where significant susceptibility differences exist between adjacent structures (e.g. tissue/air and tissuei’bone). This includes, but is not limited to, inferior brain areas such as cerebellum, internal auditory canal, vertebrae and orthopedic areas. Other high susceptibility regions include tissue in the presence of MRI compatible metallic implants, artificial joint, etc. 2. When used in the place of high resolution FSE, it will yield improved contrast-to-noise and signal-to-noise with comparable resolution and overall scan time, or improved contrast-to-noise and signal-to-noise with minimal in-plane motion-induced artifact. This may aid the trained physician in visualization of areas with reduced signal and image contrast or areas obscured by motion artifacts. It is intended for use in high-resolution anatomical regions where FSE is traditionally used, particularly in neurological imaging, where improved contrast-to-noise and signal-to-noise is needed.

Source page: https://510kreport.com/device/K031230
Methodology: https://510kreport.com/methodology