# K031089: Gore-Flex MP8 Multipurpose Torso Array

- Pathway: 510(k) (Special)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: May 8, 2003 after 31 days
- Product code: MOS (Coil, Magnetic Resonance, Specialty)
- 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: 1 generation back to K013810 (2001). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013810: Cardiovascular Array, W. L. Gore & Associates, Inc. (2001)

## Indications for use
The GORE-FLEX-MP8 Multipurpose Torso Array is intended for multiple imaging applications with GE Signa 1.5T MRI Systems, using EXCITE Technology. Its large field of view will allow for images of the complete thorax, including the heart, and its associated vasculature, the abdomen, pelvis and spine. A specialized sub-array will provide high resolution images of the thoracic region.

Source page: https://510kreport.com/device/K031089
Methodology: https://510kreport.com/methodology