# K023679: Gore 3.0T Torso Array

- Pathway: 510(k) (Traditional)
- Applicant: W. L. Gore & Associates, Inc.
- Decided: Nov 18, 2002 after 17 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 K911806 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003613: 3.0.T Signa VH/I (T/R) Body Imaging Coil, GE Medical Systems (2001) Summary page 1.
- K911806: Magnetic Resonance Diagnostic Accessory, General Electric Co. (1991) Summary page 1.

## Indications for use
The Gore 3.0T Torso Array is intended for multiple imaging applications with GE Signa(R) 3.0T MR Systems. It will allow for high resolution images of the thorax, abdomen, pelvis, and spine.

Source page: https://510kreport.com/device/K023679
Methodology: https://510kreport.com/methodology